# FDA 483 - Homtex Inc - October 16, 2025

Source: https://www.keypedia.com/records/483/homtex-inc/125ea3c5-964e-448e-ab60-72d97939d39d

> FDA 483 for Homtex Inc on October 16, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Homtex Inc
- Inspection Date: 2025-10-16
- Product Type: device
- Office Name: New Orleans District Office
- Summary: Homtex Inc, a manufacturer/spec dev in Cullman, AL, was cited with two observations during an FDA inspection. The inspection revealed significant deficiencies in acceptance activities, including undocumented testing results, lack of quality review for DHRs, and release of out-of-specification products. Additionally, the firm failed to adequately establish training procedures, with untrained personnel performing quality checks and the Director of Product Management lacking training records.

## Related Officers

- [investigator](https://www.keypedia.com/people/nikki-s-bryant/fe859d4f-23a6-4bc9-94c6-5b3c3fe8d99a)

Company: https://www.keypedia.com/companies/homtex-inc/ba2e0ff4-48b0-4c32-bfac-e105288cd746

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea