# FDA 483 - Deepwater Chemicals, Inc - February 14, 2025

Source: https://www.globalkeysolutions.net/records/483/deepwater-chemicals-inc/ec2a07d8-78fe-4437-af4c-8615131c18b1

> FDA 483 for Deepwater Chemicals, Inc on February 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Deepwater Chemicals, Inc
- Inspection Date: 2025-02-14
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Deepwater Chemicals, Inc. in Woodward, Oklahoma, an API manufacturer, received a Form 483 with five observations during an inspection from February 11-14, 2025. The inspection revealed significant deficiencies in the firm's quality control unit responsibilities, batch record management, stability testing program, laboratory controls, and cleaning verification procedures. These issues indicate a lack of adequate controls to ensure the quality and purity of active pharmaceutical ingredients.

## Related Officers

- [ CSO](https://www.globalkeysolutions.net/people/megan-t-ziegler/3e83a317-701a-4e40-bb43-34d294d3448f)
- [Margaret M. Annes](https://www.globalkeysolutions.net/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.globalkeysolutions.net/companies/deepwater-chemicals-inc/a6308d93-9a45-455c-9686-4cc16468926b

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