Hair-trigger enforcement seen as FDA sends in U.S. Marshals and negotiates consent decrees in cases without even first issuing warning letters. The agency is pushing more redacted Form 483 reports onto the web, while the second quarter warning letter rate is back up to Clinton administration levels. Meanwhile, Commissioner Hamburg announces six initiatives to expedite enforcement. Chief among them is a decision to limit Office of Chief Counsel reviews of warning letters. Another is a time clock on Form 483 responses. Additional measures would strengthen ties with other countries' enforcement agencies and establish quicker follow-up and closeout of enforcement cases. Caraco, Clarcon and Teva Animal Health quick-response cases described. read more >
Fourteen second-quarter warning letters focused on microbial contamination issues as well as mix-ups, missing data, out-of-specification reporting procedures and more read more >
June drug recalls feature massive Class II recall by Shreveport, La., repackager Advantage Dose due to cGMP nonconformance, comparable in scale and scope to Actavis Totowa, KV Pharmaceutical, Leiner Health Products recalls of recent years. read more >
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