Strategies for Surviving an FDA Audit

As part of its mission to ensure public safety, the FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. The FDA also inspects facilities that conduct clinical trials with humans and laboratories that conduct studies with animals or microorganisms when these studies are used to apply for FDA approval of a medical product. A typical inspection can last for 2-3 days and involves a number of key steps that you should be aware of.

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