FDA Posts Draft Guidance on Examples of Illegal Delay, Denial and Limiting of Drug Facility Inspectors
The Food and Drug Administration posted its draft guidance on circumstances that constitute delaying, denying, limiting, or refusing a drug facility inspection, as required be Food and Drug Administration Safety Improvement Act (FDASIA). Under the 2012 law, FDA can seek criminal penalties for delaying, limiting, or refusing drug facility inspections, and can deem the associated product adulterated in such instances.
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The draft guidance gives examples of actions that FDA considers to be delay, denying, limiting, and refusing drug facility inspections, including at the scheduling stage and during the inspection itself. Examples include refusing proposed inspection dates without a valid reason, limiting photography by the FDA inspector, limiting access to certain areas, and leaving the FDA inspector alone in a conference room for so long that it takes away from the time needed to perform the inspection.
For consideration before the guidance is finalized, comments should be submitted by Sept. 13.