Скачать или смотреть Inspection Alternatives Are Driving More FDA Enforcement Actions: What It Means for Industry

Product sampling and remote records requests accounted for most import alerts and drug GMP warning letters over FDA's fiscal year 2021. They may play a key role post-pandemic.

As remote records reviews conducted during the pandemic accounted for a growing share of warning letters, experts have advised the industry to prepare for remote FDA oversight to continue even after routine site inspections resume and the pandemic recedes.

The FDA, which historically relied solely on on-site inspections as a basis for drug adulteration warning letters, has only based 28% of warning letters issued in the first 11 months of fiscal year 2021 on-site inspections, with 62% based on sample testing and 10% on remote records reviews.

We sit down with former FDA professional, Larry Stevens, RAC, to talk about how inspection alternatives may become a permanent facet of FDA's oversight program and what companies may want to consider doing to prepare accordingly.

FDA official: Growing number of enforcement actions stem from inspection alternatives: https://www.raps.org/news-and-article... (RAPS)

Larry Stevens, RAC, has held almost every field position within FDA during his 21-year career with the Agency. He has over 18 years of experience in the medical device industry, rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers. He specializes in planning, creating, and auditing quality systems as well as creating clinical plans, including protocol development, case report form development, and implementing and managing clinical trials. He also assists in design control to meet FDA requirements. Larry is a professional speaker who regularly trains on all aspects of FDA requirements while offering practical, successful solutions to FDA problems.

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