# FDA 483 - Biomat USA, Incorporated - February 18, 2026

Source: https://www.keypedia.com/records/483/biomat-usa-incorporated/175b281d-d966-4564-870a-fda03fff116b

> FDA 483 for Biomat USA, Incorporated on February 18, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomat USA, Incorporated
- Inspection Date: 2026-02-18
- Product Type: biologics
- Office Name: Denver District Office
- Summary: Biomat USA, Incorporated in Taylorsville, UT, a source plasma firm, was cited for significant deficiencies in its plasma collection processes and quality systems. The inspection revealed failures in equipment qualification leading to uninvestigated donor overdraws, inadequate investigation of discrepancies and adverse donor reactions, and insufficient standard operating procedures for blood collection and donor safety. These issues indicate a severe lack of control over critical operations impacting donor safety and product quality.

## Related Officers

- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/biomat-usa-incorporated/757527b1-1bb4-4399-8604-7d57669ceccb

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