# FDA 483 - Evonik Corporation - August 10, 2018

Source: https://www.globalkeysolutions.net/records/483/evonik-corporation/2f9545f6-3879-4608-a2ad-ab93cb990eec

> FDA 483 for Evonik Corporation on August 10, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evonik Corporation
- Inspection Date: 2018-08-10
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Everslik Corporation Birmingham Laboratories, a sterile drug manufacturer, revealed significant deficiencies across multiple areas. The firm was cited for inadequate computer system controls, unjustified deviations from validated production processes, and insufficient laboratory testing procedures for drug implants. Additionally, the inspection found a lack of quality oversight in their equipment preventative maintenance program.

## Related Documents

- [483 - 2020-01-10](https://www.globalkeysolutions.net/records/483/evonik-corporation/f87e8806-2078-4849-9db4-44c435bd74ac)
- [483 - 2024-12-10](https://www.globalkeysolutions.net/records/483/evonik-corporation/f07b6040-6508-47e7-a302-6012a980156b)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/yubing-tang/3338f3f3-6457-48b8-86e2-97893282d2ef)
- [ Drug Investigator](https://www.globalkeysolutions.net/people/samantha-j-bradley/ba45f64f-07a9-4933-833f-b9b339c57783)

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