# FDA 483 - Omya, Inc - May 27, 2022

Source: https://www.keypedia.com/records/483/omya-inc/c15fda1a-c918-4741-94dd-205c503650f4

> FDA 483 for Omya, Inc on May 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Omya, Inc
- Inspection Date: 2022-05-27
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Omya Inc., an API manufacturer in Superior, AZ, revealed significant deficiencies in computerized system controls and quality unit oversight. The firm failed to establish appropriate controls over electronic data, including signature removal, access permissions, data deletion, and backup schedules. Additionally, the quality unit was not adequately notified of production equipment alerts and preventative maintenance work orders, hindering their ability to investigate potential quality deficiencies.

## Related Officers

- [Nathaniel B. Phillips-Sylvain](https://www.keypedia.com/people/nathaniel-b-phillips-sylvain/34a64fcb-7add-4aad-a507-4af7e2b4cf9b)
- [Hung H. Do](https://www.keypedia.com/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)

Company: https://www.keypedia.com/companies/omya-inc/d88c0314-9b75-4cd4-9be2-21d4b99ad598

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face