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Novel / Recurring deficiencies causing a FDA Warning Letter.

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John Lee, Video 4 of 9

This 4th video (out of 9 in total) focuses on novel and / or recurring deficiencies causing a FDA Warning Letter.

The video focuses on 3 deficiencies specifically, i.e.:

1. Contract Agreement – Quality Agreements:

2019 shows, that FDA has a continued strong focus on contract arrangements. This is seen in the Warning Letters issued to Contractors (Contract Manufacturers, Contract Packagers, Contract Laboratory), but also Contract Givers.
FDA is aware of, that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers and labellers. FDA regards contractors as extensions of the manufacturer.
In 2019, Warning Letters were also issued to Contract Givers. As Contract Giver (Product Owner), you are fully responsible for the quality of your drugs regardless of agreements in place with your contract facilities.

2. Raw Materials:

Raw materials supplier control is recurring issue. You must observe your suppliers’ regulatory status prior to purchasing. Who is in fact the original manufacturer? You have a pedigree responsibility.

3. Common equipment to produce non-drug product:

Common Facilities used for drug and non-drug product.

 

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.

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Novel / Recurring deficiencies causing a FDA Warning Letter.

John Lee, Video 4 of 9

Covid-19 also poses challenges to Life Science, especially within GMP-regulated environments

E.g., how do you comply with the regulatory requirements within Data Integrity in your company in connection with...

FDA-483 observations and warning letter citations 2019 – 2020

John Lee, Video 2 of 9