US FDA's Program Alignment: Where Should Form-483 Responses Go After May 15?
Now that FDA is aligning its enforcement program with its product centers on May 15, there are questions about who in the agency should receive manufacturers' 15-day responses to Form-483 inspectional observations.
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US FDA’s structure for its new pharmaceutical inspectorate, part of the massive reorganization of the Office of Regulatory Affairs, includes four domestic divisions, a fifth handling foreign inspections and the sixth handling program functions. New staff directory could prove valuable to pharmaceutical companies learning to interact with a very different field organization.
'Program Alignment' Falls Into Place: Everything You Need To Know About US FDA's New Inspectional Approach
For the medical device industry, FDA's five regional offices – Pacific, Central, Northeast, Southwest, Southeast – will be replaced by three distinct divisions across the US encompassing 20 FDA district offices on May 15. Check out the latest US map from the agency showing where the device divisions will be located, and find out what your firm will be facing at its next facility inspection.
Warning letter reveals agency found quality problems at Emergent BioSolutions’ Camden fill/finish plant during COVID-19 pandemic even as firm’s Bayview plant came under heightened scrutiny. Metal particulates appeared in vials as Camden plant and rest of Emergent’s CDMO network experienced sharp demand growth.