Everzinc Corporation – FDA 483, Jan 12, 2024

U.S. Zinc Corporation, an Active Pharmaceutical Ingredient Manufacturer in Millington, TN, was cited with two observations during an FDA inspection. The inspection revealed significant issues with data integrity, including a lack of controls over computerized systems to prevent the deletion of raw analytical data and the absence of audit trail reviews. Additionally, the firm failed to adhere to supplier recommendations for primary reference standards, using expired solutions for instrument calibration.