Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections
FDA Law Blog
JUNE 10, 2024
Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” Document all corrective actions and follow-up to ensure sustained compliance. By Sarah Wicks & Anne K. In FY2023, FDA conducted over 1000 inspections under the BIMO program.
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