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 will last for 2-3 days.

In the United States, the FDA is not required to provide advance notice of an inspection. In facilities where violations were noted during a previous inspection, the FDA will likely provide no advance notice. If your last inspection was without violation or if this is a pre-approval visit, however, you will likely be given notice of an impending inspection.

There are few events that engender as much anxiety for company stakeholders as an FDA audit. Are you prepared for when the FDA shows up at your front door? Do your employees know how to interact with FDA inspectors when they are on site? Do you have Standard Operating Procedures (SOPs) in place for handling an FDA audit?

Surviving an FDA audit can be significantly less daunting if you know what to expect and have a strategy in place to ensure the best possible outcome. In this blog, we will provide best practice guidelines to help you prepare for an FDA inspection, as well as understand how to best interact with the inspector – both while they are on site and post-inspection.

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