# FDA 483 - Evonik Corporation - December 10, 2024

Source: https://www.globalkeysolutions.net/records/483/evonik-corporation/f07b6040-6508-47e7-a302-6012a980156b

> FDA 483 for Evonik Corporation on December 10, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evonik Corporation
- Inspection Date: 2024-12-10
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Evonik Corporation in Birmingham, AL, a drug manufacturer, was cited for significant deficiencies in cleanroom controls, environmental monitoring, facility maintenance, equipment calibration, and quality unit procedures during an FDA inspection. The observations indicate a lack of adequate controls to prevent contamination and ensure proper drug product manufacturing. These issues suggest a moderate level of severity regarding GMP compliance.

## Related Documents

- [483 - 2018-08-10](https://www.globalkeysolutions.net/records/483/evonik-corporation/2f9545f6-3879-4608-a2ad-ab93cb990eec)
- [483 - 2020-01-10](https://www.globalkeysolutions.net/records/483/evonik-corporation/f87e8806-2078-4849-9db4-44c435bd74ac)

## Related Officers

- [Microbiologist](https://www.globalkeysolutions.net/people/camerson-e-moore/50733244-0d55-4b0b-a758-f192b7c66457)

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