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Audit Management Audit Readiness Checklist
Learn & access Cleaning Validation Guides
Free Download
Deviation Management Audit Readiness Checklist
Resources to Optimize and Elevate your QMS
Free Download
QMS Audit readiness Checklist
Resources to Optimize and Elevate your QMS
Free Download
Ready to Get Started?
300+ pharma facilities globally use Leucine to stay compliant. Speak with one of the expert consultants at Leucine to know how.
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Gen AI in Quality - Podcast
Check out AI Pill for Pharma here
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Gen AI in Quality - Podcast
Check out AI Pill for Pharma here
Watch Now
Glossary
Anh M Lac
FDA Investigator Details

Anh M Lac

Visit Investigator Profile

Investigation Details

Investigator ID
13209281
Last Issued Date
July 11, 2017
Conversion Rate
1
% Conversion
No. of 483’s Issued
1
Warning Letters Issued
1
Countries Inspected
USA
FDA Investigators having one site common

Detailed Analysis

Approach:

Anh M Lac employs a meticulous approach, focusing on identifying potential sources of contamination and insisting on rigorous validation and challenge testing to ensure aseptic operations are thoroughly assessed and compliant with regulations.

Profile:

Anh M Lac is a detail-oriented FDA auditor with a strong focus on contamination control, environmental monitoring, media fill, and cleaning validation in aseptic processing areas. They prioritize thorough and stringent adherence to aseptic processing standards and are particular about simulating worst-case scenarios in media fills.

Top Process Types:
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
11 Jul 2017
Park Infusioncare LP dba Preferred Homecare
Drugs
View Form 483
View Warning Letter
About
Form 483’s
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
Warning Letter
Pharmacy Plus, Inc. dba Vital Care
Drugs
Warning Letter
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Celltrion Inc.
Drugs
Pharmacy Plus, Inc. dba Vital Care
Drugs
Warning Letter
Pharmacy Plus, Inc. dba Vital Care
Drugs
Warning Letter

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

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

Get Started Now
Products
Customer
Resources
Ready to Get Started?
300+ pharma facilities globally use Leucine to stay compliant. Speak with one of the expert consultants at Leucine to know how.
Schedule Demo
Manufacturing Execution System
Quality Management System
Laboratory Execution System
Ready to Get Started?
300+ pharma facilities globally use Leucine to stay compliant. Speak with one of the expert consultants at Leucine to know how.
Schedule Demo
Audit Management Audit Readiness Checklist
Learn & access Cleaning Validation Guides
Free Download
Deviation Management Audit Readiness Checklist
Resources to Optimize and Elevate your QMS
Free Download
QMS Audit readiness Checklist
Resources to Optimize and Elevate your QMS
Free Download
Ready to Get Started?
300+ pharma facilities globally use Leucine to stay compliant. Speak with one of the expert consultants at Leucine to know how.
Schedule Demo
Gen AI in Quality - Podcast
Check out AI Pill for Pharma here
Watch Now
Gen AI in Quality - Podcast
Check out AI Pill for Pharma here
Watch Now
Glossary
Anh M Lac
FDA Investigator Details

Anh M Lac

Active
Moderately Active
Inactive
Visit Investigator Profile

Investigation Details

Last Issued Date
July 11, 2017
Form 483s Issued
1
Warning Letters Issued (since 2022)
1
Conversion Rate (483 to Warning Letter)
1
%
Investigator ID
13209281
Countries Inspected
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

Anh M Lac is a detail-oriented FDA auditor with a strong focus on contamination control, environmental monitoring, media fill, and cleaning validation in aseptic processing areas. They prioritize thorough and stringent adherence to aseptic processing standards and are particular about simulating worst-case scenarios in media fills.

Approach

Anh M Lac employs a meticulous approach, focusing on identifying potential sources of contamination and insisting on rigorous validation and challenge testing to ensure aseptic operations are thoroughly assessed and compliant with regulations.

Form 483s Issued

Issue Date
Facility Name
Product Type
483 Analysis
Converted
Warning Letter Analysis
Celltrion Inc.
Drugs
Analysis
Issue Date
Facility Name
Product Type
Form 483
Converted
Warning Letter
11 Jul 2017
Park Infusioncare LP dba Preferred Homecare
Drugs
View Form 483
View Warning Letter
About
Form 483’s
Facility Name
Product Type
483 Form
483 Analysis
Converted
Warning Letter Analysis
Celltrion Inc.
Drugs
483 URL
Analysis
Celltrion Inc.
Drugs
483 URL
Analysis
Celltrion Inc.
Drugs
483 URL
Analysis
Celltrion Inc.
Drugs
483 URL
Analysis
Celltrion Inc.
Drugs
483 URL
Analysis
Pharmacy Plus, Inc. dba Vital Care
Drugs
483 URL
Analysis
Warning Letter
Pharmacy Plus, Inc. dba Vital Care
Drugs
483 URL
Analysis
Warning Letter
Celltrion Inc.
Drugs
483 URL
Analysis
Celltrion Inc.
Drugs
483 URL
Analysis
Celltrion Inc.
Drugs
483 URL
Analysis
Pharmacy Plus, Inc. dba Vital Care
Drugs
483 URL
Analysis
Warning Letter
Pharmacy Plus, Inc. dba Vital Care
Drugs
483 URL
Analysis
Warning Letter

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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