# FDA 483 - Biomat USA, Inc. - January 09, 2025

Source: https://www.keypedia.com/records/483/biomat-usa-inc/d62f539a-27eb-4316-a12f-5422e72659a4

> FDA 483 for Biomat USA, Inc. on January 09, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomat USA, Inc.
- Inspection Date: 2025-01-09
- Product Type: biologics
- Office Name: Denver District Office
- Summary: Biomat USA, Inc. in Cedar City, UT, a source plasma firm, was cited for significant deficiencies related to equipment qualification, deviation investigations, record-keeping, and standard operating procedures. The inspection revealed failures to document investigations for malfunctioning plasmapheresis machines, incomplete documentation for discrepancies, and a lack of procedures for equipment failures. These issues indicate a systemic breakdown in quality control and record management practices.

## 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-inc/c28f6e5c-6b5f-422f-a482-3c4159472560

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