FDA 483 - Kalchem International, Inc. - December 20, 2024

An FDA inspection of Kalchem International in Lindsay, OK, from December 16-20, 2024, revealed a significant issue regarding the storage of active pharmaceutical ingredients (APIs). The firm failed to ensure that equipment used for API storage, specifically a refrigerator, was qualified for its intended use and properly segregated quarantined and approved materials. This indicates a lapse in equipment control and material management practices.