FDA WARNING_LETTER - Chromatography Institute of America dba Compounder’s International Analytical Laboratory - March 05, 2025

The FDA issued a warning letter to Chromatography Institute of America, operating as Compounder’s International Analytical Laboratory, following an inspection from February 24 to March 5, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) requirements for finished pharmaceuticals and active pharmaceutical ingredients (APIs), leading to the classification of the company"s drugs as adulterated under the Federal Food, Drug, and Cosmetic Act.

Key violations included inadequate laboratory control mechanisms, insufficient investigations into sterility test failures, and a lack of adequate Quality Unit oversight. Specifically, the firm failed to ensure the reliability of microbiological testing results, did not conduct proper investigations into sterility failures, and lacked comprehensive oversight from its Quality Unit. The company’s response to these issues was deemed inadequate by the FDA, as it did not provide sufficient evidence or corrective actions to address the identified deficiencies.

The FDA requires the company to conduct a comprehensive assessment of its global manufacturing operations to ensure compliance with CGMP standards. The firm must also inform its clients of any out-of-specification results or significant issues encountered during drug testing. The FDA emphasized the importance of operating in full compliance with CGMP to maintain the quality, safety, and efficacy of drugs tested for clients.

During the inspection, the company indicated plans to cease operations, but the FDA noted inconsistencies in the firm"s responses regarding this decision. The FDA expects a detailed response addressing the identified issues and corrective actions.