FDA 483 - Accelerated Analytical Laboratories Inc. - January 15, 2026

An FDA inspection of Accelerated Analytical Laboratories Inc., a contract laboratory in Milwaukee, revealed significant deficiencies in computer system controls related to the testing of OTC drug products. The firm failed to validate electronic software systems, did not fully review primary electronic data and audit trails, and permitted the use of shared administrative login credentials in the microbiology lab. These issues indicate a lack of appropriate controls to ensure data integrity and compliance with GMP requirements.