FDA 483 - Advanced Testing Laboratory, Inc. - November 09, 2023

An FDA inspection of Advanced Testing Laboratory, Inc., a contract testing laboratory in Blue Ash, OH, revealed significant deficiencies in their quality system. The firm failed to adhere to its own standard operating procedures for investigations and change control, leading to unrecorded deviations and retesting without justification. Additionally, laboratory records were found to be incomplete, lacking proper data access controls and second-person review, and complaint procedures were deficient, resulting in untimely initiation and closure of deviations, OOSs, and client complaints.