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Experience firsthand how Leucine's 10x MES digitalizes batch records, streamlines production, and provides real-time monitoring of your manufacturing operations. Schedule a personalized demo to discover how our AI-powered platform can enhance your productivity while maintaining compliance.

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See how Leucine's 10x QMS automates compliance workflows, streamlines change control, and ensures regulatory adherence. Schedule a demo to learn how our AI-powered platform can help you manage quality processes more efficiently while reducing compliance risks.

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Watch how Leucine's 10x LES orchestrates your lab operations, automates documentation, and ensures data integrity. Schedule a demo to see how our AI-powered platform can accelerate your testing processes while maintaining audit-readiness.

Optimize your manufacturing processes with paperless operations
Strengthen quality management and regulatory compliance
Accelerate laboratory operations and testing workflows
Glossary
Sena G Dissmeyer
FDA Investigator Details

Sena G Dissmeyer

Visit Investigator Profile

Investigation Details

Investigator ID
13209281
Last Issued Date
July 14, 2023
Conversion Rate
0
% Conversion
No. of 483’s Issued
13
Warning Letters Issued
2
Countries Inspected
USA

Detailed Analysis

Approach:

Sena G Dissmeyer takes a systematic approach to inspections, focusing on the cleanliness and contamination control measures, as well as assessing the consistency of drug product quality. He pays particular attention to non-microbial contamination, residues, and potential cross-contamination.

Profile:

Sena G Dissmeyer is a detail-oriented FDA auditor who focuses on contamination control, cleanliness, and product quality. He has a keen interest in ensuring the cleanliness of production areas, eliminating non-microbial contamination, and preventing cross-contamination. He also closely scrutinizes drug product quality and potential issues related to product strength.

Top Process Types:
  • Contamination Control
  • Environmental Monitoring
  • Training Management
  • Cleaning Validation
  • Media Fill
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
14 Jul 2023
Sentara Enterprises dba Sentara Infusion Services (Blue Ridge)
Drugs
14 Jul 2023
Sentara Enterprises dba Sentara Infusion Services (Blue Ridge)
Drugs
16 Dec 2022
Sentara Infusion Services
Drugs
09 Sep 2022
Curexa - East, LLC dba Curexa
Drugs
05 Aug 2022
ImprimisRx NJ
Drugs
02 Dec 2021
Valgene Incorporated dba Cape Drugs
Drugs
08 Oct 2021
InfuScience, Inc. dba Bioscrip Infusion Services
Drugs
30 Jul 2019
InfuScience, Inc. dba Bioscrip Infusion Services
Drugs
12 Jul 2019
Keystone Rx LLC
Drugs
05 Sep 2018
Arnold Professional Pharmacy
Drugs
05 Sep 2018
Arnold Professional Pharmacy
Drugs
07 Aug 2018
PharmScript, LLC
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

Unlock Insights from 483s & Stay Audit Ready with FDA Tracker

Monitor FDA Six Systems, Analyse 483s with Observations, Investigators & Companies

Get Started Now

Experience AI.
Powered Pharma Operations

Transform Your Pharma Operations with AI-Powered Intelligence. Experience how Leucine's integrated platform brings together manufacturing, quality, and laboratory operations in one digital ecosystem. Schedule a personalized demo to see how our AI solutions can optimize your processes, ensure compliance, and drive operational excellence.

See How AI Transforms Your Shop Floor Operations.
Experience firsthand how Leucine's 10x MES digitalizes batch records, streamlines production, and provides real-time monitoring of your manufacturing operations. Schedule a personalized demo to discover how our AI-powered platform can enhance your productivity while maintaining compliance.

Experience AI-Driven Quality Management in Action.
See how Leucine's 10x QMS automates compliance workflows, streamlines change control, and ensures regulatory adherence. Schedule a demo to learn how our AI-powered platform can help you manage quality processes more efficiently while reducing compliance risks.

Discover Smart Laboratory Operations Management.
Watch how Leucine's 10x LES orchestrates your lab operations, automates documentation, and ensures data integrity. Schedule a demo to see how our AI-powered platform can accelerate your testing processes while maintaining audit-readiness.

Optimize your manufacturing processes with paperless operations
Strengthen quality management and regulatory compliance
Accelerate laboratory operations and testing workflows
Glossary
Sena G Dissmeyer

Sena G Dissmeyer

Data since January 01, 2022
Moderately Active
Active
Moderately Active
Inactive
View Detailed Investigator Profile

Investigation Details

Last Issued Date
July 14, 2023
Form 483s Issued
13
Warning Letters Issued (since 2022)
2
Conversion Rate (483 to Warning Letter)
0
%
Investigator ID
13209281
Countries Inspected
USA

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

Form 483 Issued by Year

Form 483s
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.

Top 5 Sub-Systems

Subsystem
Occurrences
Detailed Analysis
Contamination Control
22
Environmental Monitoring
11
Training Management
10
Cleaning Validation
4
Media Fill
4
Unblock Complete Sub-Systems Insights

Top 5 Co-Investigators

Co-Investigator
Joint Inspections
Details
Tekalign Wondimu
3
Russell J Glapion
1
David A Oluwo
1
Jessica S Estriplet
1
Natasha Gupta
1
-
Explore Full Investigator Network
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.

Top 5 Sub-Systems

Subsystem
Occurrences
Detailed Analysis
Contamination Control
22
Environmental Monitoring
11
Training Management
10
Cleaning Validation
4
Media Fill
4

Top 5 Co-Investigators

Co-Investigator
Joint Inspections
Details
Tekalign Wondimu
3
Russell J Glapion
1
David A Oluwo
1
Jessica S Estriplet
1
Natasha Gupta
1
-

Investigator Analysis

Profile

Sena G Dissmeyer is a detail-oriented FDA auditor who focuses on contamination control, cleanliness, and product quality. He has a keen interest in ensuring the cleanliness of production areas, eliminating non-microbial contamination, and preventing cross-contamination. He also closely scrutinizes drug product quality and potential issues related to product strength.

Approach

Sena G Dissmeyer takes a systematic approach to inspections, focusing on the cleanliness and contamination control measures, as well as assessing the consistency of drug product quality. He pays particular attention to non-microbial contamination, residues, and potential cross-contamination.

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
14 Jul 2023
Sentara Enterprises dba Sentara Infusion Services (Blue Ridge)
Drugs
14 Jul 2023
Sentara Enterprises dba Sentara Infusion Services (Blue Ridge)
Drugs
16 Dec 2022
Sentara Infusion Services
Drugs
09 Sep 2022
Curexa - East, LLC dba Curexa
Drugs
05 Aug 2022
ImprimisRx NJ
Drugs
02 Dec 2021
Valgene Incorporated dba Cape Drugs
Drugs
08 Oct 2021
InfuScience, Inc. dba Bioscrip Infusion Services
Drugs
30 Jul 2019
InfuScience, Inc. dba Bioscrip Infusion Services
Drugs
12 Jul 2019
Keystone Rx LLC
Drugs
05 Sep 2018
Arnold Professional Pharmacy
Drugs
05 Sep 2018
Arnold Professional Pharmacy
Drugs
07 Aug 2018
PharmScript, LLC
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

Unlock Insights from 483s & Stay Audit Ready with FDA Tracker

Monitor FDA Six Systems, Analyse 483s with Observations, Investigators & Companies

Get Started Now

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