The Federal Food, Drug, and Cosmetic Act prohibits facilities from denying, delaying, or limiting FDA inspections, or their products may be considered adulterated. This policy has been in place for drug facilities since 2012, but was only extended to medical devices in 2017 under the FDA Reauthorization Act. The FDA has finalized a revision to its guidance on this subject, providing more examples and considerations specific to medical devices. The guidance outlines actions that would constitute delaying, denying, limiting, or refusing an inspection, and the consequences for noncompliance. The final guidance includes new examples and clarifications for both drug and device facilities, emphasizing the importance of timely and comprehensive inspections. Companies can refer to FDA warning letters and inspection reports for insight into how the agency enforces this policy in practice. This update serves to provide clarity and consistency in the enforcement of inspection regulations for both drug and device manufacturers.
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