An FDA drug investigator reports on the ways SOPs and data can introduce unneeded risks in quality management systems.
Enforcement this week included two drug GMP warning letters, both to firms in the US.
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Enforcement included only two warning letters this week: we cover one BIMO warning letter and one issued to an OTC drug firm. The OTC firms continue to show that they have a limited grasp of the fundamentals of GMPs required for their product type. Also, Lupin announced that they received a warning letter but FDA has not yet published it.
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.
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.