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.
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 posted seven warning letters this week, among which was one to a finish pharmaceutical manufacturer. We cover that warning letter here.
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.
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.
FDA published three drug warning letters this week, one of which was issued in April and one that found a firm to be shredding GMP documents.