# FDA 483 - Everzinc Corporation - January 12, 2024

Source: https://www.keypedia.com/records/483/everzinc-corporation/2cc3b833-8ce4-4313-abc5-12dd5f80e794

> FDA 483 for Everzinc Corporation on January 12, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Everzinc Corporation
- Inspection Date: 2024-01-12
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: 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.

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Company: https://www.keypedia.com/companies/everzinc-corporation/55741828-4588-4a30-ad5a-6a2e008ad2c0

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea