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Showstopper GMP Violations. FDA Drug GMP

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John Lee, Video 3 of 9

This 3rd video (out of 9 in total) focuses on showstopper GMP Violations, or in other words, very critical deficiencies causing a Warning Letter.

This includes Warning Letters with Single GMP Citation, e.g.

• Lack of / inadequate QCU oversight, responsibilities and authority
• Data Integrity
• Providing falsified data to FDA Investigator
• Failure to validate test methods

These single issues alone could potentially lead to a Warning Letter.

In general, you can access FDA's Inspection Citation database. The citations data contained in the linked spreadsheet reflect data pulled from FDA's electronic inspection tools. It covers general citations, e.g. Drug, Device and Part 11 Compliance (easy-copy link):





The video is recorded during the COVID-19 US lock-down by John Lee with mobile recording equipment, and the quality could be better. Focus on the great presentation and content instead.

The statistics can be downloaded as an E-book:

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CEO & Seniorkonsulent
IT & Automation / GAMP, Regulatory Affairs, Project Management, Management Consulting, GMP, Træning

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