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Learn & access Cleaning Validation Guides
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Resources to Optimize and Elevate your QMS
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Check out AI Pill for Pharma here
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Glossary
Christopher D Leach
FDA Investigator Details

Christopher D Leach

Visit Investigator Profile

Investigation Details

Investigator ID
13209281
Last Issued Date
May 22, 2017
Conversion Rate
0
% Conversion
No. of 483’s Issued
5
Warning Letters Issued
1
Countries Inspected
USA
FDA Investigators having one site common

Detailed Analysis

Approach:

Leach looks for adherence to sterile production procedures and maintains a significant focus on the competence of personnel in observing aseptic techniques. He stresses the need for written stability testing and its actual implementation while also exercising vigilance in ensuring that sterility tests are consistently performed.

Profile:

Christopher D Leach appears to be a thorough investigator with a pronounced focus on sterile production procedures and personnel hygiene habits, likely indicating a background in microbiology or a related field. He emphasises both the need for written stability testing and the actual execution of these programs. His reports highlight a consistent stance on ensuring sterility at every step of the manufacturing process.

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
22 May 2017
Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy
Drugs
View Form 483
View Warning Letter
21 Sep 2016
Option Care
Drugs
View Form 483
04 Jan 2016
Pharmedium Services, LLC
Drugs
View Form 483
01 Mar 2013
Oakdell Pharmacy, Inc
Drugs
View Form 483
01 Mar 2013
Oakdell Pharmacy, Inc
Drugs
View Form 483
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
Christopher D Leach
FDA Investigator Details

Christopher D Leach

Active
Moderately Active
Inactive
Visit Investigator Profile

Investigation Details

Last Issued Date
May 22, 2017
Form 483s Issued
5
Warning Letters Issued (since 2022)
1
Conversion Rate (483 to Warning Letter)
0
%
Investigator ID
13209281
Countries Inspected
USA
FDA Investigators having one site common

Lucas B Leake , Bryan L Mcguckin

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

Christopher D Leach appears to be a thorough investigator with a pronounced focus on sterile production procedures and personnel hygiene habits, likely indicating a background in microbiology or a related field. He emphasises both the need for written stability testing and the actual execution of these programs. His reports highlight a consistent stance on ensuring sterility at every step of the manufacturing process.

Approach

Leach looks for adherence to sterile production procedures and maintains a significant focus on the competence of personnel in observing aseptic techniques. He stresses the need for written stability testing and its actual implementation while also exercising vigilance in ensuring that sterility tests are consistently performed.

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
22 May 2017
Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy
Drugs
View Form 483
View Warning Letter
21 Sep 2016
Option Care
Drugs
View Form 483
04 Jan 2016
Pharmedium Services, LLC
Drugs
View Form 483
01 Mar 2013
Oakdell Pharmacy, Inc
Drugs
View Form 483
01 Mar 2013
Oakdell Pharmacy, Inc
Drugs
View Form 483
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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