# FDA 483 - Biomat USA Inc - November 06, 2025

Source: https://www.keypedia.com/records/483/biomat-usa-inc/607903a9-d858-411f-be61-0fa745ed6f6e

> FDA 483 for Biomat USA Inc on November 06, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomat USA Inc
- Inspection Date: 2025-11-06
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of Biomat USA Inc in Killeen, TX, from November 3-6, 2025, revealed a significant failure to perform thorough investigations into unexplained discrepancies. Specifically, the firm's CAPA investigations did not adequately address an employee's deliberate entry of false quality control results for donor hematocrit testing, nor did they fully correct repeated failures to record cannula lot numbers for collected source plasma. These issues indicate serious deficiencies in the firm's quality system and investigation processes, potentially impacting donor eligibility and product safety.

## Related Documents

- [483 - 2025-11-06](https://www.keypedia.com/records/483/biomat-usa-inc/f0d612b4-f949-49c7-a311-72c842af3ec7)

## Related Officers

- [investigator](https://www.keypedia.com/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)

Company: https://www.keypedia.com/companies/biomat-usa-inc/6b275f7a-a5af-4c01-8b51-0f022826ccc5

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