FDA 483 - Analytical Food Laboratories Inc. - May 17, 2024

The FDA conducted an inspection of Analytical Food Laboratories Inc., a contract testing laboratory in Grand Prairie, TX, between May 7 and May 17, 2024. The inspection revealed significant deficiencies in the firm's quality management systems and laboratory operations, indicating a lack of adherence to regulatory expectations for drug product testing.

Key observations included a failure by the Quality Unit to establish written procedures and ensure validation or verification of test methods for drug products. Multiple test methods lacked documented accuracy and suitability, with specific examples of unvalidated assays. Laboratory controls were found inadequate, with an absence of proper specifications, insufficient system suitability for HPLC analyses, and poor documentation for solution preparation. The firm also used outdated calibration curves, lacked justification for reagent expiration dates, and compromised microbiological testing by preparing samples in uncontrolled environments and performing incomplete media growth promotions.

Further issues involved a failure to thoroughly investigate unexplained discrepancies or out-of-specification results, including re-running tests without proper documentation or Quality Unit oversight. Laboratory records were incomplete, particularly regarding mobile phase preparation. Equipment qualification and calibration were deficient, with a TOC analyzer and autoclaves not properly qualified or re-qualified, pH meters incorrectly calibrated, and inaccurate balance performance checks. Lastly, employees performing drug product testing lacked essential training in current good manufacturing practices (GMP), and relevant training records were not provided. Analytical Food Laboratories Inc. is required to implement comprehensive corrective actions to address these systemic issues, ensuring all procedures, equipment, records, and personnel training meet regulatory standards for drug product quality and safety.