FDA Finalizes Guidance on Examples of Illegal Impediments to Drug Facility Inspectors
The Food and Drug Administration finalized a guidance document outlining circumstances that constitute delaying, denying, limiting, or refusing a drug facility inspection. Under the Food and Drug Administration Safety Improvement Act (FDASIA) of 2012, 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 guidance gives examples of actions that FDA considers as impeding 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, failure to produce records, 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. The final version of the guidance also includes explanations the agency would deem reasonable for denying, delaying, or limiting an inspection.