FDA Investigators Share Advice on Responding to Form 483 Reports
This article was originally published in The Gold Sheet
Initial responses to Form 483 reports don’t have to be completely thorough, but they must arrive within 15 days, an FDA investigator says. Other advice from investigators includes pointers on how to tell if the findings are egregious.
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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.
Agency may share outcomes of remote record reviews in lieu of inspections at US and foreign facilities.
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