FDA 483 - C.A.T. GmbH and Co. KG - March 20, 2012

From March 16 to March 20, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of C.A.T. Gmbh and Co. KG, a contract testing laboratory located in Tubingen, Germany. The inspection evaluated the firm"s compliance with laboratory control mechanisms and established test procedures. The primary violation identified during the inspection involves the failure of the firm to implement adequate system suitability tests for chromatographic methods, specifically as outlined in USP <621>. The investigator observed that the laboratory did not perform replicate injections of standard solutions to verify system precision during the analysis of residual solvents and optical purity for multiple lots of Active Pharmaceutical Ingredients (APIs). Instead, the firm relied on a single injection of standard solutions, which is insufficient to confirm the effectiveness of the analytical system. Furthermore, the firm failed to conduct required injections at defined intervals or after the final sample injection to ensure system stability throughout the testing sequence. These findings suggest a lack of proper oversight by the quality control unit regarding the drafting and approval of testing protocols. Under the FDA’s regulatory framework, these observations constitute significant deviations from standard laboratory practices. While the FDA 483 does not represent a final determination of compliance, C.A.T. Gmbh and Co. KG is required to address these issues. The firm must submit a corrective action plan detailing how they will update their procedures to ensure all future chromatography runs include the necessary system suitability checks to guarantee the accuracy and reliability of their testing results.