# FDA 483 - Evonik Corporation - January 10, 2020

Source: https://www.globalkeysolutions.net/records/483/evonik-corporation/f87e8806-2078-4849-9db4-44c435bd74ac

> FDA 483 for Evonik Corporation on January 10, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evonik Corporation
- Inspection Date: 2020-01-10
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Evernik Corporation Birmingham Laboratories, a sterile drug manufacturer in Birmingham, AL, was inspected by the FDA from January 6-10, 2020. The inspection revealed significant deficiencies across multiple areas, including equipment design, laboratory controls, data integrity, contamination prevention, and inadequate written procedures for production and process controls. Additionally, the firm failed to ensure sufficient GMP training for employees, indicating a broad lack of adherence to current good manufacturing practices.

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## Related Officers

- [CO CDER OMQ](https://www.globalkeysolutions.net/people/claire-minden/f48982ad-244e-41a8-932a-5d7a2392f0e3)

Company: https://www.globalkeysolutions.net/companies/evonik-corporation/f88f3afa-3508-4fc2-8d70-8558ece37d59

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