Pace Analytical Services, LLC – FDA 483, Jul 8, 2026

Pace Analytical Services, LLC in Madisonville, KY, a contract testing laboratory, was cited for significant deficiencies in its laboratory controls and data integrity practices. Observations included inadequate computer system controls, failure to back up electronic data, use of unvalidated test methods, and lack of proper second-person review of laboratory records. These issues indicate a serious lack of adherence to good manufacturing practices, potentially impacting the quality and reliability of drug product testing.