# FDA 483 - Evonik Active Oxygens, LLC - November 06, 2024

Source: https://www.keypedia.com/records/483/evonik-active-oxygens-llc/77f9b1d5-a394-4bb7-bfb9-91f033c9367e

> FDA 483 for Evonik Active Oxygens, LLC on November 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evonik Active Oxygens, LLC
- Inspection Date: 2024-11-06
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Evonik Active Oxygens, LLC, an API manufacturer in Pasadena, TX, revealed significant deficiencies in computerized system controls and quality system procedures. The firm failed to secure laboratory computer access and did not adequately document or investigate deviations, conduct mock recalls, or implement corrective actions for identified non-conformances. These issues indicate a lack of robust controls over data integrity and quality management.

## Related Officers

- [investigator](https://www.keypedia.com/people/timothy-h-vo/08da7ca5-7f58-42bf-8046-e3a1bf879b48)

Company: https://www.keypedia.com/companies/evonik-active-oxygens-llc/3f4770f9-f6d2-49a9-8b6c-84e89f10a5e6

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9