Loading…
Chromatography Institute of America, a contract testing laboratory in Colorado, was cited for significant Current Good Manufacturing Practice (CGMP) violations in its testing of active pharmaceutical ingredients (APIs) and finished drug products for human and animal use, rendering those drugs adulterated. During a February-March 2025 inspection, the FDA identified inadequate laboratory control mechanisms, specifically that the firm used identical methods and procedures across testing of APIs, outsourcing facility compounded products, and finished drugs without appropriate differentiation. The violations suggest the company failed to maintain adequate controls and procedures necessary to ensure the quality and safety of the products it tested.