Enforcement includes one untitled letter and one warning letter to cell therapy companies. Also, FDA posted and then removed one warning letter to a device manufacturer.
A busy week for enforcement. Included in this week of warning letters are Dollar Tree (in which FD&C Act is cited rather than CFR), Cadila Healthcare Limited, and Mylan Laboratories Limited among others.
A slow week for drug and device warning letters as FDA continues their enforcement focus on e-cigarette suppliers. Enforcement this week includes a lone GMP warning letter to a PET drug manufacturer.
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There were six warning letter postings during this week, including one regarding Akorn’s site in Somerset, NJ that the company announced a few weeks ago.