FDA 483 - Analytical Food Laboratories Inc. - June 20, 2025

Analytical Food Laboratories Inc. in Grand Prairie, TX, a contract testing laboratory, was cited for significant deficiencies in its Quality Unit's oversight of cGMP drug product testing operations. The inspection revealed repeat observations regarding the failure to verify CAPA effectiveness, inadequate laboratory controls, and issues with consultant qualification, cleaning validation, and equipment calibration. These findings indicate a systemic lack of adherence to regulatory requirements for drug product testing.