GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters

Updated August 4, 2024

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Warning Letters - FDA.gov

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Read the full article: GMP News: Insufficient failure investigations, supplier qualification, stability testing - the most common GMP violations in the FDA warning letters:

"The analysis of the warning letters issued in the last fiscal year shows no surprise at a first glance: as in recent years the FDA detected an insufficient investigation of unexplained discrepancies and deviations from defined standards and specifications in their inspections. The corresponding paragraph 21 CFR 211.192 

that the drug maker clarifies the reason for the deviation, takes corrective actions and also creates a complete documentation. In the last 5-year period on average annually about 22 companies received a warning letter listing this GMP deficiency. This fact shows that many quality assurance departments' understanding of deviations handling, failure investigations and corrective actions is frequently fragmentary."

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The Only Vote That Counts: FDA 483 Round-Up

The Only Vote That Counts: FDA 483 Round-Up:

"Looking at the FDA isn’t much different. Lots of folks like to predict what the FDA will do, or try to glean trends from the often cryptic public statements FDA officials make at conferences or other gatherings.  But the FDAs real “votes” are in the 483s they issue.

Reading through a recently-released crop of the agency’s medical device letters, it looks like the FDA is maintaing an interest in CAPA and employee training."

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Warning: Your “Check CAPA” Light is On - FDA Form 483

Warning: Your “Check CAPA” Light is On | Ask Cato:

The FDA has reported that over 50% of the top 10 Form FDA 483 observations and warning letters are related to one process: CAPA, otherwise known as Corrective and Preventive Actions.

"The requirements are summarized as follows:

1. Analyze processes to identify the root cause of the nonconformance and to proactively identify potential causes of future nonconformance;
2. Investigate the cause;
3. Identify actions needed to correct and prevent nonconformance recurrence;
4. Validate that the CAPA is effective and does not cause unintended adverse effects;
5. Implement and record changes in procedures to correct and prevent the recurrence of noncompliance;
6. Ensure direct dissemination of CAPA information to those responsible for assuring product quality to ensure adequate training for preventive actions; and
7. Submit the relevant documentation on CAPA for management review."

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FDA Wants Resource Planning In Corrective Action Plans

According to the The QA Pharm blog,

"The most successful corrective action plans have been those where the direct responsible individuals are named and appear in detailed project plans. There is a clear picture of what success looks like and how to get there. But most of all, the resources are identified to execute the work."

Apparently in an FDA Warning Letter to Teva early this year,  the FDA is telegraphing their desire to see these kinds of elements in a response:

• a plan
• what kind of data will be collected to measure the effectiveness of the plan
• a timeline for the plan
• the identification of resources allocated to address the issue

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Top 10 - Reasons Why CAPA or Deviation Investigation Systems Fail

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I ran across this post on The QA Pharm Blog,  The Top Ten Reasons the Deviation Investigation System Fails. It's a good read amongst some other pretty thought-provoking posts.

In a nutshell:

"Warning Letters are fraught with observations that point to issues with the deviation investigation system and the ability to solve problems once and for all. Here are my top ten reasons that the deviation/investigation/CAPA system fails: . . . "

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Root Cause Analysis for Better Investigations by SkillsPlus Intl Inc.

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CAPA Basics - Carl Anderson and Barbara Immel

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I always enjoy running across well-written GXP articles.  Kudos to Carl for posting this informative CAPA Basics article by Barbara Immel on his blog (GXP Perspectives), CAPA Basics- Corrective And Preventative Action.

I've been following Barbara Immel's writing for some time, and always pick up several pearls of wisdom from her.

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CAPA Problems - Most often cited 483 deficiency

You'll do well by reading this well-written article by Barbara Immel, "Converting CAPA to an Advantage - CAPA violations still generate a substantial number of warning letters. These tips can help make CAPA systems a benefit instead of a liability." Her writings are packed full of great content. Don't miss out on these pearls of wisdom and well referenced article.

In concluding, she writes, "CAPA deficiencies are one of the most common items cited in warning letters to medical device manufacturers. Therefore, it is critical for manufacturers to understand how to develop a CAPA system and how best to use it. . . ."

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Medical Device Sponsors - FDA Trends and Tips To Avoid 483s

Updated November 5, 2024

The original link broke

You might also be interested in this article by the same author, Carl Anderson:

The FDA 483 - https://carl1anderson.wordpress.com/wp-content/uploads/2009/03/the-fda-483.pdf

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The Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration, released inspection statistics for the 2007 fiscal year. The statistics for the 40 Bioresearch Monitoring (BIMO) inspections of medical device sponsors showed serious concerns for compliance with good clinical practice (GCP) regulations. Author Carl Anderson explains the CDRH findings, identifies problem areas to avoid, and gives tips on how to avoid 483s, in his article, "Trends in FDA CDRH Bioresearch Monitoring Inspections." The following are the topics he covers in the article . . .

• About the Division of Bioresearch Monitoring Organization at CDRH
• Medical Device Sponsor Inspections
• Quality Systems in Clinical Trials
• Implications of BIMO Inspection Statistics - with a top 5 category list of deficiencies

Don't get caught flat-footed. Reading this article will help you steer clear of choppy waters, warnings, and 483s.

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