Enforced 15-day limit on FDA form 483 responses

Posted by cdavenport on Wednesday Oct 7, 2009 Under News Releases

Starting 15 September 2009, the FDA began enforcing a 15-day limit on post-inspection responses to an FDA-issued form 483  (Inspectional Observations).   Upon  completion of a facility inspection, the FDA may issue a form 483  to notify an inspected establishment’s top management of objectionable conditions.  These conditions may relate to products, processes, or other violations of the Federal Food, Drug, and Cosmetic Act (and related acts) that were observed during the inspection.  In the past, late and/or multiple responses to a FDA form 483 have delayed the issuance of warning letters while these responses were reviewed and addressed.  Under the current paradigm, however, ongoing or promised corrective actions may not preclude the issuance of a warning letter by the Agency.   The program’s goal is to optimize FDA’s already strained resources and to move firms to promptly correct noted violations.  The program will be assessed by the FDA after approximately 18 months.

Sources:  PharmTechTalk and Federal Register.

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