FDA 483 - Zochem LLC - November 21, 2024

Zochem, LLC, an Active Pharmaceutical Ingredient (API) manufacturer in Dickson, TN, was cited with four observations during an FDA inspection from November 18-21, 2024. The inspection revealed significant deficiencies in the firm's quality control unit, including repeated failures in deviation investigations, equipment calibration procedures, raw material handling, vendor qualification, and process validation. Additionally, issues were noted with incomplete laboratory control records, inadequate computerized system controls, and improper storage of reserve samples for their Zinc Oxide API product.