Always Inspection Ready: Mastering FDA Inspection Preparation and Response

[Article Title]

The COVID-19 pandemic reshaped FDA inspection processes, leading to a lasting global backlog and stricter oversight. Companies now face more rigorous onsite, remote, and unannounced inspections. In an American Pharmaceutical Review webinar, experts Anita Michael and Steven Lynn of Regulatory Compliance Associates, a Nelson Labs Company, shared key strategies for staying inspection-ready. As Lynn noted, “Inspections are getting much more deep and rigorous. When an investigator shows up at your front door, you’re going to have a pretty darn tough inspection, so always be ready.”

This article explores the current regulatory landscape of unannounced and remote inspections, pitfalls in inspection readiness, building an inspection-ready organization, and more.

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