Kalchem International, Inc.December 20, 2024

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

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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.

Company: Kalchem International, Inc.
Inspection Date: December 20, 2024
Product Type: Drugs
Office: Dallas District Office
Person: Demario L. Walls (Investigator)

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