Recent Warning Letters Show Ongoing Problems with OOS Investigations and Inadequate Root Cause Analysis
This article was originally published in The Gold Sheet
Recent GMP warning letters focused on root cause, OOS investigations
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Recent GMP warning letters featured data integrity issues.
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.
Hospitals will have a large role in success of these treatments, with a high level of teamwork and coordination required between the technical operations team and the commercial teams working in tight time-frames.