Over the years, the FDAzilla blog has published over 650 articles. We hope this compilation will serve as a resource for you and your company. It should also help orient you to the scope of the FDAzilla blog as you continue to follow our efforts to provide accessible FDA data and insights.
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.
This week, there were two warning letters issued to pharmaceutical firms. But first, we address an EIR associated with AveXis and the second warning letter issued to a firm for failure to comply with the Food Foreign Supplier Verification Program.
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.
We cover three GMP drug warning letters and a warning letter to a large CBD firm for misbranding and distribution of the unapproved new drug. FDA did not agree with the firm’s statement that the product was a dietary supplement.