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, 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.  

In this episode, 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-articles/news-articles/2021/11/fda-official-says-increasing-number-of-enforcement (RAPS)   

About Larry Stevens, RAC: Larry 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.  

Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more and get the conversation started: www.thefdagroup.com