# FDA 483 - Biomat USA Inc - April 14, 2026

Source: https://www.keypedia.com/records/483/biomat-usa-inc/5127aaa3-7d41-4dbb-ae68-104e012c044a

> FDA 483 for Biomat USA Inc on April 14, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomat USA Inc
- Inspection Date: 2026-04-14
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of Biomat USA Inc.'s source plasma establishment in Lufkin, TX, revealed significant deficiencies across four observations. The firm failed to properly present educational materials to donors, conduct thorough investigations into discrepancies, and maintain accurate donor and processing records. Additionally, employees did not consistently follow written standard operating procedures for blood collection and storage.

## Related Officers

- [Elyshia Q. Danaher](https://www.keypedia.com/people/elyshia-q-danaher/73046c15-abb1-431e-8a76-59c7e8c1604a)

Company: https://www.keypedia.com/companies/biomat-usa-inc/49424971-1c03-4233-80ea-a6572e5fae2a

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