Among FDA-posted warning letters this week, the Center for Tobacco Products posted four warning letters, one GMP drug warning letter from CDER and yet another, the 4th, warning letter regarding failure to comply with the Foreign [Food] Supplier Verification Program (FSVP) posted this week.
FDA posted three drug warning letters this week, one of which was issued regarding combination products. FDA’s requests for “independent” assessments continue.
We took a snapshot of the seven warning letters FDA sent to food and dietary supplement companies that were posted in October. Violations range from misbranding to the presence of Listeria monocytogenes.
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.
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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’.