SEARCH LESS KNOW MORE
The essential tool for compliance, regulatory, and quality professionals
Lots of reading, including more to OTC manufacturers who continue to fail to understand and implement the fundamentals of GMPs. There is also one warning letter to a cell therapy manufacturer and one to a sponsor-investigator.
Join President of FOI Services, Marlene Bobka, for an informative 1-hour webinar about all things FOIA. Gain a deeper understanding of the internal workings of FDA and help prevent legal actions, financial penalties and other costly errors at your company.
This week, there were a total of five issued warning letters: three were issued to drug manufacturers, one to a compounding pharmacy, and one to a device manufacturer. The first one issued to Deva Holdings addresses severe penicillin cross-contamination.
GMP expert Barbara W. Unger analyzes the major initiatives put forth in CDER's Office of Compliance Annual Report for CY2018.
We cover three drug warning letters, one issued to a compounding pharmacy, one device warning letter, and one in the food area that is a ‘first of its kind’.
FDA issued a particularly harsh press release on August 6, 2019 addressing the data accuracy issues with the BLA for the gene therapy product, Zolgensma, which was approved by FDA on May 24, 2019. It seems the FDA is using them, and more importantly their parent company Novartis, as an example of what not to do.
FDA posted seven warning letters this week, among which was one to a finish pharmaceutical manufacturer. We cover that warning letter here.
The second and final part of this report will cover the actions firms can take to prevent, identify, and remediate issues as well as summarizing the trends of data integrity failures.
FDA posted five warning letters this week although none are drug or device GMP warning letters. However, two warning letters that we cover here were identified as posted on July 23rd. For any of you who also follow warning letters closely, be cautious about putting too much faith in FDA’s posting dates for the warning letters.
GMP expert Barbara W. Unger evaluates data integrity deficiencies from CY2018 and presents the trends since CY2008.