10 Tips - How to Avoid FDA 483 and Warning Letters

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Updated February 15, 2021

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Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations in Medical Device Environments - MasterControl

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It never hurts to review or re-review your policies and procedures. 

Check out this white paper, Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations. 

Previous Posts: 

• CAPA Problems - Most often cited 483 deficiency 
• More FDA 483 Resources - Comments and Pearls from Validation Online 
• FDA 483 Inspectional Observations - learn from these examples 

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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. . . ."

Related Posts:
Free FDA Compliance Library (Immel Resources LLC - Pharmaceutical, Medical Device, Biologics and Related Industries)
FDA Says - Unwise To Ignore Form 483
Medical Device Sponsors - FDA Trends and Tips To Avoid 483s
More FDA 483 Resources - Comments and Pearls from Validation Online
FDA 483 Inspectional Observations - learn from these examples

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