FDA Investigator Details

ET

Visit Investigator Profile

Investigation Details

Investigator ID
13209281
Last Issued Date
Conversion Rate
0
% Conversion
No. of 483’s Issued
249
Warning Letters Issued
26
Countries Inspected
Belgium, CHINA, China, Iceland, India, Japan, Malaysia, Puerto Rico, Republic of Korea, South Korea, Spain, Switzerland, USA
FDA Investigators having one site common

Detailed Analysis

Approach:

With a thorough and meticulous approach, ''ET'' prioritizes in-depth documentation, validation, and compliance with regulatory standards. ''ET'' focuses on ensuring the adequacy and effectiveness of controls and procedures in pharmaceutical manufacturing and reporting.

Profile:

The FDA auditor ''ET'' shows a strong focus on Quality Control, microbiological contamination prevention, cleaning and disinfecting procedures, deviation handling, environmental monitoring, drug testing, component handling, adverse event reporting, product labeling, and regulatory reporting compliance. ''ET'' is detail-oriented, with a keen interest in aseptic processes and sterile cleanroom conditions. ''ET'' also emphasizes adherence to regulatory standards related to drug testing and reporting.

Top Process Types:
  • Contamination Control
  • Environmental Monitoring
  • Investigations
  • Document Management
  • Data Integrity
Observation Categories
Critical

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.
Major

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.
Minor

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.
Issue Date
Facility Name
Product Type
483 Analysis
Converted
Warning Letter Analysis
Celltrion Inc.
Drugs
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
01 Aug 2024
Adaptimmune LLC
Drugs
12 Jun 2024
Torrent Pharmaceuticals Limited
Drugs
31 May 2024
ModernaTX Inc.
Drugs
24 May 2024
Mylan Laboratories Limited
Drugs
16 Jan 2024
Jiangsu Hengrui Pharmaceuticals Co., Ltd
Drugs
08 Dec 2023
Vertex Pharmaceuticals Incorporated
Drugs
08 Sep 2023
Sichuan Deebio Pharmaceutical Co. Ltd.
Drugs
31 Jul 2023
Central Admixture Pharmacy Services, Inc.
Drugs
29 Jun 2023
BioMarin Pharmaceutical Inc.
Drugs
21 Jun 2023
Sarepta Therapeutics, Inc.
Drugs
17 May 2023
SCA Pharmaceuticals, Inc.
Drugs
12 May 2023
Intas Pharmaceuticals Limited
Drugs
03 May 2023
GlaxoSmithKline Biologicals SA
Drugs
10 Mar 2023
Hugel, Inc. (Site 2)
Drugs
21 Feb 2023
Bioverativ Therapeutics, Inc.
Drugs
10 Feb 2023
Nephron Sterile Compounding Center LLC
Drugs
10 Feb 2023
AGC Biologics Inc.
Drugs
18 Nov 2022
Aurobindo Pharma Limited Unit IX
Drugs
21 Oct 2022
Rx Unlimited Pharmacy
Drugs
14 Oct 2022
QuVa Pharma, Inc.
Drugs
30 Sep 2022
Qualgen, LLC
Drugs
09 Sep 2022
Curexa - East, LLC dba Curexa
Drugs
30 Aug 2022
Biocon Sdn. Bhd.
Drugs
26 Aug 2022
Biocon Biologics Limited
Drugs
12 Aug 2022
iRhythm Technologies, Inc.
Drugs
11 Aug 2022
Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy
Drugs
05 Aug 2022
Empower Clinic Services LLC dba Empower Pharmacy
Drugs
27 Jun 2022
Right Value Drug Stores, LLC dba Carie
Drugs
27 Jun 2022
Laboratorios Farmaceuticos Rovi S. A.
Drugs
14 Jun 2022
FARMAKEIO OUTSOURCING LLC
Drugs
09 May 2022
Sun Pharmaceutical Industries Ltd.
Drugs
20 Apr 2022
Nephron Sterile Compounding Center LLC
Drugs
15 Apr 2022
Lynn Oaks Compounding Pharmacy
Drugs
30 Mar 2022
Novel Laboratories, Inc. d.b.a Lupin Somerset
Drugs
22 Mar 2022
Alvotech Hf
Drugs
18 Mar 2022
Abbott Laboratories dba Abbott Nutrition
Drugs
18 Mar 2022
Abbott Laboratories dba Abbott Nutrition
Drugs
25 Feb 2022
Central Admixture Pharmacy Services
Drugs
18 Feb 2022
Davis City Pharmacy Inc.
Drugs
11 Feb 2022
Family Dollar Distribution Inc.
Drugs
04 Feb 2022
Bioiberica, S.A.U
Drugs
17 Dec 2021
Compound Preferred LLC
Drugs
18 Nov 2021
Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy
Drugs
15 Oct 2021
Abbott Nutrition
Drugs
30 Sep 2021
OurPharma LLC
Drugs
24 Sep 2021
Biocon Sdn. Bhd.
Drugs
24 Sep 2021
Abbott Nutrition
Drugs
23 Sep 2021
OSRX, Inc. dba Pinnacle Compounding
Drugs
22 Sep 2021
Montana Compounding Pharmacy P.C.
Drugs
24 Aug 2021
Samsung Biologics Co., Ltd.
Drugs
26 Jul 2021
Colonia Care Pharmacy
Drugs
23 Jul 2021
Integrated Health Concepts Inc.
Drugs
15 Jun 2021
Qualgen LLC
Drugs
21 Apr 2021
Fujifilm Diosynth Biotechnologies USA, Inc.
Drugs
25 Feb 2021
Toyobo Co. Ltd.
Drugs
29 Jan 2021
Imprimis NJOF, LLC
Drugs
05 Oct 2020
Providence Health and Services
Drugs
06 Apr 2020
CareFusion 303, Inc.
Drugs
24 Jan 2020
Claremore Compounding Center, Inc.
Drugs
26 Nov 2019
Takeda Pharmaceutical Company Limited
Drugs
25 Oct 2019
Aurobindo Pharma Limited
Drugs
03 Oct 2019
MCALISTER DRUG CORPORATION
Drugs
23 Aug 2019
Ipca Laboratories Limited
Drugs
23 Aug 2019
East Marietta Drug Company
Drugs
25 Jul 2019
Mandell's Clinical Pharmacy
Drugs
13 Jun 2019
Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center
Drugs
13 Jun 2019
Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center
Drugs
24 May 2019
Aurobindo Pharma Ltd
Drugs
29 Apr 2019
Colonia Care Pharmacy
Drugs
14 Mar 2019
QuVa Pharma, Inc.
Drugs
19 Dec 2018
Flourish Integrative Pharmacy, LLC
Drugs
13 Nov 2018
Avella Specialty Pharma
Drugs
13 Sep 2018
Qualgen LLC
Drugs
17 Aug 2018
HomeChoice Partners, Inc.
Drugs
17 Aug 2018
HomeChoice Partners, Inc.
Drugs
17 Aug 2018
HomeChoice Partners, Inc.
Drugs
15 Aug 2018
Auro Pharmacies, Inc.
Drugs
15 Aug 2018
Auro Pharmacies, Inc.
Drugs
02 Aug 2018
Auro Pharmacies, Inc.
Drugs
01 Aug 2018
Immunomedics, Inc.
Drugs
27 Jul 2018
Medcraft LLC
Drugs
19 Jul 2018
Actavis Laboratories FL, Inc.
Drugs
13 Jul 2018
Sharp Drugs, Inc.
Drugs
11 Jul 2018
CFP Acquisitions, Inc.
Drugs
24 May 2018
Glenmark Pharmaceuticals Ltd
Drugs
25 Apr 2018
Avella of Deer Valley dba Avella Specialty Pharmacy
Drugs
24 Apr 2018
Zimmer Biomet, Inc.
Drugs
24 Apr 2018
Zimmer Biomet, Inc.
Drugs
19 Apr 2018
Avella Specialty Pharma
Drugs
12 Apr 2018
Mylan Pharmaceuticals Inc.
Drugs
08 Mar 2018
Edge Pharmacy Services, LLC
Drugs
13 Dec 2017
PharMEDium Services, LLC
Drugs
07 Dec 2017
Peoples Pharmacy, Inc.
Drugs
07 Dec 2017
Peoples Pharmacy, Inc.
Drugs
21 Nov 2017
Trone Health Services, Inc.
Drugs
17 Nov 2017
Yuki Gosei Kogyo Co., Ltd.
Drugs
11 Aug 2017
Zhejiang Hisun Pharmaceutical Co., Ltd.
Drugs
02 Aug 2017
Kelley-Ross Compounding Pharmacy
Drugs
01 Aug 2017
Kelley-Ross Compounding Pharmacy
Drugs
24 May 2017
Pharmacy Associates, Inc.
Drugs
10 May 2017
Qualgen, LLC
Drugs
21 Apr 2017
Nephron Pharmaceuticals Corporation
Drugs
07 Apr 2017
Biocon Limited
Drugs
04 Apr 2017
Dr. Reddy's Laboratories Limited
Drugs
15 Mar 2017
Dixie Dew Products Inc
Drugs
23 Feb 2017
Delta Pharma, Inc.
Drugs
21 Feb 2017
Dr. Reddy's Laboratories Ltd
Drugs
14 Feb 2017
Nutripack LLC
Drugs
20 Jan 2017
Sancilio & Company, Inc.
Drugs
19 Jan 2017
Zhejiang Hisun Pharmaceutical Co., Ltd.
Drugs
22 Nov 2016
Zimmer Biomet, Inc.
Drugs
18 Nov 2016
Zhejiang Huahai Pharmaceutical Co. Ltd
Drugs
21 Sep 2016
Fagron Compounding Services LLC dba Fagron Sterile Services
Drugs
31 Aug 2016
KRS Global Biotechnology, Inc
Drugs
17 Aug 2016
Zhejiang Bangli Medical Products Co., Ltd.
Drugs
28 Jul 2016
Hybrid Pharma LLC
Drugs
15 Jul 2016
Sincerus Florida, LLC
Drugs
06 Jul 2016
Lupin Limited
Drugs
13 Jun 2016
PREMIER PHARMACY LABS INC.
Drugs
08 Jun 2016
Hospira Inc. A Pfizer Company
Drugs
25 Mar 2016
Catalent Pharma Solutions, LLC
Drugs
02 Mar 2016
Stonegate Pharmacy LP
Drugs
02 Mar 2016
Stonegate Pharmacy LP
Drugs
25 Feb 2016
Option Care Enterprises, Inc.
Drugs
29 Jan 2016
Central Admixture Pharmacy Services
Drugs
21 Jan 2016
Pacifico National Inc. dba Amex Pharmacy
Drugs
29 Dec 2015
Dartmouth Hitchcock Medical Center
Drugs
18 Dec 2015
The General Hospital Corporation
Drugs
11 Dec 2015
Huntington Memorial Hospital
Drugs
03 Dec 2015
JCB Laboratories LLC
Drugs
17 Sep 2015
Qualgen LLC
Drugs
14 Sep 2015
RC Compounding Services, LLC
Drugs
29 Jul 2015
Avella of Deer Valley, Inc. dba Avella
Drugs
17 Jul 2015
Lupin Limited
Drugs
18 Jun 2015
Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory
Drugs
28 May 2015
The Wellness Center Pharmacy, Inc., dba Designer Drugs
Drugs
30 Apr 2015
Blue Bell Creameries Inc
Drugs
13 Mar 2015
The Apothecary Shoppe, LLC
Drugs
20 Feb 2015
Lato Drug Company, Inc. d.b.a. Post Haste Pharmacy
Drugs
19 Feb 2015
Physician Preferred Medical, LLC
Drugs
05 Feb 2015
Infupharma LLC
Drugs
16 Jan 2015
Advanced Physician Solutions, Inc.
Drugs
31 Dec 2014
McGuff Compounding Pharmacy Services, Inc.
Drugs
12 Dec 2014
Right Value Drug Stores, Inc.
Drugs
21 Nov 2014
Exela Pharma Sciences, LLC
Drugs
12 Aug 2014
Complete Pharmacy & Medical Solutions LLC
Drugs
28 Jul 2014
Peoples Pharmacy, Inc. #2
Drugs
16 May 2014
Healix Infusion Therapy, Inc.
Drugs
16 May 2014
Healix Infusion Therapy, Inc.
Drugs
15 Apr 2014
Edwards Lifesciences, LLC
Drugs
13 Dec 2013
Brookfield Prescription Center Inc. dba MD Custom Rx
Drugs
04 Nov 2013
Cantrell Drug Company
Drugs
13 Sep 2013
Specialty Compounding, LLC
Drugs
13 Sep 2013
Specialty Compounding, LLC
Drugs
26 Jul 2013
Wells Pharmacy Network LLC
Drugs
19 Jul 2013
Beacon Hill Medical Pharmacy, P.C.
Drugs
25 Mar 2013
The Compounding Shop, Inc.
Drugs
22 Mar 2013
Specialty Compounding, LLC
Drugs
22 Mar 2013
Specialty Compounding, LLC
Drugs
22 Mar 2013
The Compounding Shop, Inc.
Drugs
22 Mar 2013
THE COMPOUNDING SHOP, INC.
Drugs
08 Mar 2013
Lowlyn Pharmacies, Inc.
Drugs
08 Mar 2013
Lowlyn Pharmacies, Inc.
Drugs
27 Feb 2013
JCB Labs LLC
Drugs
25 Feb 2013
Avella of Deer Valley, Inc.
Drugs
25 Feb 2013
Avella of Deer Valley, Inc.
Drugs
22 Feb 2013
Anazaohealth Corporation
Drugs
22 Feb 2013
Anazaohealth Corporation
Drugs
13 Nov 2012
Dyna Labs, LLC
Drugs
09 Nov 2012
Ameridose, LLC
Drugs
09 Nov 2012
Ameridose, LLC
Drugs
08 Nov 2012
ARL Biopharma, Inc. dba Analytical Research Laboratories
Drugs
17 Oct 2012
St. Jude Medical IESD
Drugs
17 Oct 2012
St. Jude Medical IESD
Drugs
24 Aug 2012
Hospira, Inc.
Drugs
24 Aug 2012
Hospira, Inc.
Drugs
28 Mar 2012
Impax Laboratories, Inc.
Drugs
28 Mar 2012
Impax Laboratories, Inc.
Drugs
27 Sep 2011
Infupharma, LLC
Drugs
27 Sep 2011
Genentech Inc
Drugs
22 Jul 2011
Zimmer Inc.
Drugs
23 Jun 2011
Lamar Zimmerman
Drugs
17 Jun 2011
Hospira, Inc.
Drugs
01 Jun 2011
Burns Poultry Farm, Inc.
Drugs
01 Jun 2011
Burns Poultry Farm, Inc.
Drugs
25 May 2011
Ben Venue Laboratories, Inc.
Drugs
20 May 2011
Donald J. Martin Farm
Drugs
20 May 2011
Donald J. Martin Farm
Drugs
11 May 2011
Williamette Egg Farms dba Satrum Egg Ranch
Drugs
06 May 2011
Willamette Egg Farms LLC
Drugs
05 May 2011
Sparboe Farms / Prairie Complex
Drugs
28 Apr 2011
Rose Acre Farms, Inc.
Drugs
28 Apr 2011
Rose Acre Farms, Inc.
Drugs
28 Apr 2011
Rose Acre Farms, Inc.
Drugs
25 Apr 2011
E. Lavern Martin Farm
Drugs
25 Apr 2011
E. Lavern Martin Farm
Drugs
20 Apr 2011
Jordan Egg Farm, Inc.
Drugs
20 Apr 2011
Jordan Egg Farm, Inc.
Drugs
08 Apr 2011
Quint T Egg Farm
Drugs
08 Apr 2011
Quint T Egg Farm
Drugs
17 Mar 2011
Gary Miller Farm
Drugs
11 Mar 2011
Armstrong Farms Inc.
Drugs
10 Mar 2011
Alvin Weaver
Drugs
10 Mar 2011
Alvin Weaver
Drugs
11 Feb 2011
Arlin D. Wadel, Owner
Drugs
11 Feb 2011
Arlin D. Wadel, Owner
Drugs
28 Jan 2011
Tiny Greens
Drugs
15 Oct 2010
ISE America, Inc./ISE Newberry, Inc
Drugs
13 Sep 2010
American National Red Cross (The)
Drugs
12 May 2010
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.
Drugs
12 May 2010
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.
Drugs
30 Apr 2010
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.
Drugs
23 Feb 2010
Thumb Oilseed Producers' Cooperative
Drugs
23 Dec 2009
AnazaoHealth Corporation
Drugs
23 Dec 2009
Amylin Pharmaceuticals Inc
Drugs
19 Oct 2009
Matrixx Initiatives Inc
Drugs
19 Oct 2009
Matrixx Initiatives Inc
Drugs
15 Jul 2009
Plainview Milk Products Cooperative
Drugs
15 Jul 2009
Plainview Milk Products Cooperative
Drugs
30 May 2009
Bi-County Farm Bureau Coop Association Inc.
Drugs
30 May 2009
Bi-County Farm Bureau Coop Association Inc.
Drugs
10 Mar 2009
Sunland, Inc.
Drugs
05 Feb 2009
Peanut Corporation of America
Drugs
27 Jan 2009
Peanut Corporation of America
Drugs
27 Jan 2009
Perrigo Florida Inc dba Unico
Drugs
13 Aug 2007
ApotheCure Inc
Drugs
15 May 2006
Bausch & Lomb Inc
Drugs
18 Apr 2006
Andrx Pharmaceuticals, Inc.
Drugs
26 Aug 2005
Boston Scientific Corporation
Drugs
20 May 2005
Boston Scientific Corporation
Drugs
07 Apr 2005
Boston Scientific Corporation
Drugs
05 Feb 2004
Peregrina Cheese Company
Drugs
19 Mar 2003
Peregrina Cheese Company
Drugs
14 Feb 2003
CryoLife
Drugs
31 Jan 2003
University of Illinois @ Urbana-Champaign
Drugs
09 Sep 2002
McNeil Consumer & Specialty Pharmaceuticals
Drugs
13 Jun 2001
Schering-Plough Products, L.L.C.
Drugs
09 Mar 2000
McNeil Consumer Healthcare
Drugs
Facility Name
Product Type
483 Form
483 Analysis
Converted
Warning Letter Analysis
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Pharmacy Plus, Inc. dba Vital Care
Drugs
Pharmacy Plus, Inc. dba Vital Care
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Pharmacy Plus, Inc. dba Vital Care
Drugs
Pharmacy Plus, Inc. dba Vital Care
Drugs

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FDA Investigator Details

ET

Active
Moderately Active
Inactive
Visit Investigator Profile

Investigation Details

Last Issued Date
Form 483s Issued
249
Warning Letters Issued (since 2022)
26
Conversion Rate (483 to Warning Letter)
0
%
Investigator ID
13209281
Countries Inspected
Belgium, CHINA, China, Iceland, India, Japan, Malaysia, Puerto Rico, Republic of Korea, South Korea, Spain, Switzerland, USA
FDA Investigators having one site common

483s Issues in Countries

Countries
No of Investigation Done
United States of America
230
United Kingdom
120
India
72
United Arab Emirates
53
Australia
18
Observation Categories
Critical

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.
Major

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.
Minor

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.
Observation Categories
Critical

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.
Major

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.
Minor

What’s a Rich Text element?

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Investigator Analysis

Profile

The FDA auditor ''ET'' shows a strong focus on Quality Control, microbiological contamination prevention, cleaning and disinfecting procedures, deviation handling, environmental monitoring, drug testing, component handling, adverse event reporting, product labeling, and regulatory reporting compliance. ''ET'' is detail-oriented, with a keen interest in aseptic processes and sterile cleanroom conditions. ''ET'' also emphasizes adherence to regulatory standards related to drug testing and reporting.

Approach

With a thorough and meticulous approach, ''ET'' prioritizes in-depth documentation, validation, and compliance with regulatory standards. ''ET'' focuses on ensuring the adequacy and effectiveness of controls and procedures in pharmaceutical manufacturing and reporting.

Form 483s Issued

Issue Date
Facility Name
Product Type
483 Analysis
Converted
Warning Letter Analysis
Celltrion Inc.
Drugs
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
01 Aug 2024
Adaptimmune LLC
Drugs
12 Jun 2024
Torrent Pharmaceuticals Limited
Drugs
31 May 2024
ModernaTX Inc.
Drugs
24 May 2024
Mylan Laboratories Limited
Drugs
16 Jan 2024
Jiangsu Hengrui Pharmaceuticals Co., Ltd
Drugs
08 Dec 2023
Vertex Pharmaceuticals Incorporated
Drugs
08 Sep 2023
Sichuan Deebio Pharmaceutical Co. Ltd.
Drugs
31 Jul 2023
Central Admixture Pharmacy Services, Inc.
Drugs
29 Jun 2023
BioMarin Pharmaceutical Inc.
Drugs
21 Jun 2023
Sarepta Therapeutics, Inc.
Drugs
17 May 2023
SCA Pharmaceuticals, Inc.
Drugs
12 May 2023
Intas Pharmaceuticals Limited
Drugs
03 May 2023
GlaxoSmithKline Biologicals SA
Drugs
10 Mar 2023
Hugel, Inc. (Site 2)
Drugs
21 Feb 2023
Bioverativ Therapeutics, Inc.
Drugs
10 Feb 2023
Nephron Sterile Compounding Center LLC
Drugs
10 Feb 2023
AGC Biologics Inc.
Drugs
18 Nov 2022
Aurobindo Pharma Limited Unit IX
Drugs
21 Oct 2022
Rx Unlimited Pharmacy
Drugs
14 Oct 2022
QuVa Pharma, Inc.
Drugs
30 Sep 2022
Qualgen, LLC
Drugs
09 Sep 2022
Curexa - East, LLC dba Curexa
Drugs
30 Aug 2022
Biocon Sdn. Bhd.
Drugs
26 Aug 2022
Biocon Biologics Limited
Drugs
12 Aug 2022
iRhythm Technologies, Inc.
Drugs
11 Aug 2022
Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy
Drugs
05 Aug 2022
Empower Clinic Services LLC dba Empower Pharmacy
Drugs
27 Jun 2022
Right Value Drug Stores, LLC dba Carie
Drugs
27 Jun 2022
Laboratorios Farmaceuticos Rovi S. A.
Drugs
14 Jun 2022
FARMAKEIO OUTSOURCING LLC
Drugs
09 May 2022
Sun Pharmaceutical Industries Ltd.
Drugs
20 Apr 2022
Nephron Sterile Compounding Center LLC
Drugs
15 Apr 2022
Lynn Oaks Compounding Pharmacy
Drugs
30 Mar 2022
Novel Laboratories, Inc. d.b.a Lupin Somerset
Drugs
22 Mar 2022
Alvotech Hf
Drugs
18 Mar 2022
Abbott Laboratories dba Abbott Nutrition
Drugs
18 Mar 2022
Abbott Laboratories dba Abbott Nutrition
Drugs
25 Feb 2022
Central Admixture Pharmacy Services
Drugs
18 Feb 2022
Davis City Pharmacy Inc.
Drugs
11 Feb 2022
Family Dollar Distribution Inc.
Drugs
04 Feb 2022
Bioiberica, S.A.U
Drugs
17 Dec 2021
Compound Preferred LLC
Drugs
18 Nov 2021
Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy
Drugs
15 Oct 2021
Abbott Nutrition
Drugs
30 Sep 2021
OurPharma LLC
Drugs
24 Sep 2021
Biocon Sdn. Bhd.
Drugs
24 Sep 2021
Abbott Nutrition
Drugs
23 Sep 2021
OSRX, Inc. dba Pinnacle Compounding
Drugs
22 Sep 2021
Montana Compounding Pharmacy P.C.
Drugs
24 Aug 2021
Samsung Biologics Co., Ltd.
Drugs
26 Jul 2021
Colonia Care Pharmacy
Drugs
23 Jul 2021
Integrated Health Concepts Inc.
Drugs
15 Jun 2021
Qualgen LLC
Drugs
21 Apr 2021
Fujifilm Diosynth Biotechnologies USA, Inc.
Drugs
25 Feb 2021
Toyobo Co. Ltd.
Drugs
29 Jan 2021
Imprimis NJOF, LLC
Drugs
05 Oct 2020
Providence Health and Services
Drugs
06 Apr 2020
CareFusion 303, Inc.
Drugs
24 Jan 2020
Claremore Compounding Center, Inc.
Drugs
26 Nov 2019
Takeda Pharmaceutical Company Limited
Drugs
25 Oct 2019
Aurobindo Pharma Limited
Drugs
03 Oct 2019
MCALISTER DRUG CORPORATION
Drugs
23 Aug 2019
Ipca Laboratories Limited
Drugs
23 Aug 2019
East Marietta Drug Company
Drugs
25 Jul 2019
Mandell's Clinical Pharmacy
Drugs
13 Jun 2019
Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center
Drugs
13 Jun 2019
Puget Sound Drug Corporation dba Key Pharmacy and Compounding Center
Drugs
24 May 2019
Aurobindo Pharma Ltd
Drugs
29 Apr 2019
Colonia Care Pharmacy
Drugs
14 Mar 2019
QuVa Pharma, Inc.
Drugs
19 Dec 2018
Flourish Integrative Pharmacy, LLC
Drugs
13 Nov 2018
Avella Specialty Pharma
Drugs
13 Sep 2018
Qualgen LLC
Drugs
17 Aug 2018
HomeChoice Partners, Inc.
Drugs
17 Aug 2018
HomeChoice Partners, Inc.
Drugs
17 Aug 2018
HomeChoice Partners, Inc.
Drugs
15 Aug 2018
Auro Pharmacies, Inc.
Drugs
15 Aug 2018
Auro Pharmacies, Inc.
Drugs
02 Aug 2018
Auro Pharmacies, Inc.
Drugs
01 Aug 2018
Immunomedics, Inc.
Drugs
27 Jul 2018
Medcraft LLC
Drugs
19 Jul 2018
Actavis Laboratories FL, Inc.
Drugs
13 Jul 2018
Sharp Drugs, Inc.
Drugs
11 Jul 2018
CFP Acquisitions, Inc.
Drugs
24 May 2018
Glenmark Pharmaceuticals Ltd
Drugs
25 Apr 2018
Avella of Deer Valley dba Avella Specialty Pharmacy
Drugs
24 Apr 2018
Zimmer Biomet, Inc.
Drugs
24 Apr 2018
Zimmer Biomet, Inc.
Drugs
19 Apr 2018
Avella Specialty Pharma
Drugs
12 Apr 2018
Mylan Pharmaceuticals Inc.
Drugs
08 Mar 2018
Edge Pharmacy Services, LLC
Drugs
13 Dec 2017
PharMEDium Services, LLC
Drugs
07 Dec 2017
Peoples Pharmacy, Inc.
Drugs
07 Dec 2017
Peoples Pharmacy, Inc.
Drugs
21 Nov 2017
Trone Health Services, Inc.
Drugs
17 Nov 2017
Yuki Gosei Kogyo Co., Ltd.
Drugs
11 Aug 2017
Zhejiang Hisun Pharmaceutical Co., Ltd.
Drugs
02 Aug 2017
Kelley-Ross Compounding Pharmacy
Drugs
01 Aug 2017
Kelley-Ross Compounding Pharmacy
Drugs
24 May 2017
Pharmacy Associates, Inc.
Drugs
10 May 2017
Qualgen, LLC
Drugs
21 Apr 2017
Nephron Pharmaceuticals Corporation
Drugs
07 Apr 2017
Biocon Limited
Drugs
04 Apr 2017
Dr. Reddy's Laboratories Limited
Drugs
15 Mar 2017
Dixie Dew Products Inc
Drugs
23 Feb 2017
Delta Pharma, Inc.
Drugs
21 Feb 2017
Dr. Reddy's Laboratories Ltd
Drugs
14 Feb 2017
Nutripack LLC
Drugs
20 Jan 2017
Sancilio & Company, Inc.
Drugs
19 Jan 2017
Zhejiang Hisun Pharmaceutical Co., Ltd.
Drugs
22 Nov 2016
Zimmer Biomet, Inc.
Drugs
18 Nov 2016
Zhejiang Huahai Pharmaceutical Co. Ltd
Drugs
21 Sep 2016
Fagron Compounding Services LLC dba Fagron Sterile Services
Drugs
31 Aug 2016
KRS Global Biotechnology, Inc
Drugs
17 Aug 2016
Zhejiang Bangli Medical Products Co., Ltd.
Drugs
28 Jul 2016
Hybrid Pharma LLC
Drugs
15 Jul 2016
Sincerus Florida, LLC
Drugs
06 Jul 2016
Lupin Limited
Drugs
13 Jun 2016
PREMIER PHARMACY LABS INC.
Drugs
08 Jun 2016
Hospira Inc. A Pfizer Company
Drugs
25 Mar 2016
Catalent Pharma Solutions, LLC
Drugs
02 Mar 2016
Stonegate Pharmacy LP
Drugs
02 Mar 2016
Stonegate Pharmacy LP
Drugs
25 Feb 2016
Option Care Enterprises, Inc.
Drugs
29 Jan 2016
Central Admixture Pharmacy Services
Drugs
21 Jan 2016
Pacifico National Inc. dba Amex Pharmacy
Drugs
29 Dec 2015
Dartmouth Hitchcock Medical Center
Drugs
18 Dec 2015
The General Hospital Corporation
Drugs
11 Dec 2015
Huntington Memorial Hospital
Drugs
03 Dec 2015
JCB Laboratories LLC
Drugs
17 Sep 2015
Qualgen LLC
Drugs
14 Sep 2015
RC Compounding Services, LLC
Drugs
29 Jul 2015
Avella of Deer Valley, Inc. dba Avella
Drugs
17 Jul 2015
Lupin Limited
Drugs
18 Jun 2015
Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory
Drugs
28 May 2015
The Wellness Center Pharmacy, Inc., dba Designer Drugs
Drugs
30 Apr 2015
Blue Bell Creameries Inc
Drugs
13 Mar 2015
The Apothecary Shoppe, LLC
Drugs
20 Feb 2015
Lato Drug Company, Inc. d.b.a. Post Haste Pharmacy
Drugs
19 Feb 2015
Physician Preferred Medical, LLC
Drugs
05 Feb 2015
Infupharma LLC
Drugs
16 Jan 2015
Advanced Physician Solutions, Inc.
Drugs
31 Dec 2014
McGuff Compounding Pharmacy Services, Inc.
Drugs
12 Dec 2014
Right Value Drug Stores, Inc.
Drugs
21 Nov 2014
Exela Pharma Sciences, LLC
Drugs
12 Aug 2014
Complete Pharmacy & Medical Solutions LLC
Drugs
28 Jul 2014
Peoples Pharmacy, Inc. #2
Drugs
16 May 2014
Healix Infusion Therapy, Inc.
Drugs
16 May 2014
Healix Infusion Therapy, Inc.
Drugs
15 Apr 2014
Edwards Lifesciences, LLC
Drugs
13 Dec 2013
Brookfield Prescription Center Inc. dba MD Custom Rx
Drugs
04 Nov 2013
Cantrell Drug Company
Drugs
13 Sep 2013
Specialty Compounding, LLC
Drugs
13 Sep 2013
Specialty Compounding, LLC
Drugs
26 Jul 2013
Wells Pharmacy Network LLC
Drugs
19 Jul 2013
Beacon Hill Medical Pharmacy, P.C.
Drugs
25 Mar 2013
The Compounding Shop, Inc.
Drugs
22 Mar 2013
Specialty Compounding, LLC
Drugs
22 Mar 2013
Specialty Compounding, LLC
Drugs
22 Mar 2013
The Compounding Shop, Inc.
Drugs
22 Mar 2013
THE COMPOUNDING SHOP, INC.
Drugs
08 Mar 2013
Lowlyn Pharmacies, Inc.
Drugs
08 Mar 2013
Lowlyn Pharmacies, Inc.
Drugs
27 Feb 2013
JCB Labs LLC
Drugs
25 Feb 2013
Avella of Deer Valley, Inc.
Drugs
25 Feb 2013
Avella of Deer Valley, Inc.
Drugs
22 Feb 2013
Anazaohealth Corporation
Drugs
22 Feb 2013
Anazaohealth Corporation
Drugs
13 Nov 2012
Dyna Labs, LLC
Drugs
09 Nov 2012
Ameridose, LLC
Drugs
09 Nov 2012
Ameridose, LLC
Drugs
08 Nov 2012
ARL Biopharma, Inc. dba Analytical Research Laboratories
Drugs
17 Oct 2012
St. Jude Medical IESD
Drugs
17 Oct 2012
St. Jude Medical IESD
Drugs
24 Aug 2012
Hospira, Inc.
Drugs
24 Aug 2012
Hospira, Inc.
Drugs
28 Mar 2012
Impax Laboratories, Inc.
Drugs
28 Mar 2012
Impax Laboratories, Inc.
Drugs
27 Sep 2011
Infupharma, LLC
Drugs
27 Sep 2011
Genentech Inc
Drugs
22 Jul 2011
Zimmer Inc.
Drugs
23 Jun 2011
Lamar Zimmerman
Drugs
17 Jun 2011
Hospira, Inc.
Drugs
01 Jun 2011
Burns Poultry Farm, Inc.
Drugs
01 Jun 2011
Burns Poultry Farm, Inc.
Drugs
25 May 2011
Ben Venue Laboratories, Inc.
Drugs
20 May 2011
Donald J. Martin Farm
Drugs
20 May 2011
Donald J. Martin Farm
Drugs
11 May 2011
Williamette Egg Farms dba Satrum Egg Ranch
Drugs
06 May 2011
Willamette Egg Farms LLC
Drugs
05 May 2011
Sparboe Farms / Prairie Complex
Drugs
28 Apr 2011
Rose Acre Farms, Inc.
Drugs
28 Apr 2011
Rose Acre Farms, Inc.
Drugs
28 Apr 2011
Rose Acre Farms, Inc.
Drugs
25 Apr 2011
E. Lavern Martin Farm
Drugs
25 Apr 2011
E. Lavern Martin Farm
Drugs
20 Apr 2011
Jordan Egg Farm, Inc.
Drugs
20 Apr 2011
Jordan Egg Farm, Inc.
Drugs
08 Apr 2011
Quint T Egg Farm
Drugs
08 Apr 2011
Quint T Egg Farm
Drugs
17 Mar 2011
Gary Miller Farm
Drugs
11 Mar 2011
Armstrong Farms Inc.
Drugs
10 Mar 2011
Alvin Weaver
Drugs
10 Mar 2011
Alvin Weaver
Drugs
11 Feb 2011
Arlin D. Wadel, Owner
Drugs
11 Feb 2011
Arlin D. Wadel, Owner
Drugs
28 Jan 2011
Tiny Greens
Drugs
15 Oct 2010
ISE America, Inc./ISE Newberry, Inc
Drugs
13 Sep 2010
American National Red Cross (The)
Drugs
12 May 2010
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.
Drugs
12 May 2010
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.
Drugs
30 Apr 2010
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc.
Drugs
23 Feb 2010
Thumb Oilseed Producers' Cooperative
Drugs
23 Dec 2009
AnazaoHealth Corporation
Drugs
23 Dec 2009
Amylin Pharmaceuticals Inc
Drugs
19 Oct 2009
Matrixx Initiatives Inc
Drugs
19 Oct 2009
Matrixx Initiatives Inc
Drugs
15 Jul 2009
Plainview Milk Products Cooperative
Drugs
15 Jul 2009
Plainview Milk Products Cooperative
Drugs
30 May 2009
Bi-County Farm Bureau Coop Association Inc.
Drugs
30 May 2009
Bi-County Farm Bureau Coop Association Inc.
Drugs
10 Mar 2009
Sunland, Inc.
Drugs
05 Feb 2009
Peanut Corporation of America
Drugs
27 Jan 2009
Peanut Corporation of America
Drugs
27 Jan 2009
Perrigo Florida Inc dba Unico
Drugs
13 Aug 2007
ApotheCure Inc
Drugs
15 May 2006
Bausch & Lomb Inc
Drugs
18 Apr 2006
Andrx Pharmaceuticals, Inc.
Drugs
26 Aug 2005
Boston Scientific Corporation
Drugs
20 May 2005
Boston Scientific Corporation
Drugs
07 Apr 2005
Boston Scientific Corporation
Drugs
05 Feb 2004
Peregrina Cheese Company
Drugs
19 Mar 2003
Peregrina Cheese Company
Drugs
14 Feb 2003
CryoLife
Drugs
31 Jan 2003
University of Illinois @ Urbana-Champaign
Drugs
09 Sep 2002
McNeil Consumer & Specialty Pharmaceuticals
Drugs
13 Jun 2001
Schering-Plough Products, L.L.C.
Drugs
09 Mar 2000
McNeil Consumer Healthcare
Drugs
Facility Name
Product Type
483 Form
483 Analysis
Converted
Warning Letter Analysis
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Pharmacy Plus, Inc. dba Vital Care
Drugs
Pharmacy Plus, Inc. dba Vital Care
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Pharmacy Plus, Inc. dba Vital Care
Drugs
Pharmacy Plus, Inc. dba Vital Care
Drugs

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