FDA 483 - Compounders International Analytical Laboratory - March 05, 2025

Chromatography Institute of America, Inc. in Castle Rock, CO, a contract testing laboratory, was cited for numerous significant quality control and laboratory control deficiencies. These include inadequate OOS investigations, lack of validated procedures for sterility testing and media, poor data integrity controls, and a complete failure to maintain a complaint log. The findings indicate systemic issues across quality assurance, laboratory operations, and data management.