483
Kalchem International, Inc.Kalchem International, Inc. – FDA 483, Dec 20, 2024
Record Details
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.
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ID · cab0584e-f298-45f4-8e40-5e8e892d7a6b
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