# FDA 483 - Biomat USA Inc - February 04, 2026

Source: https://www.keypedia.com/records/483/biomat-usa-inc/d09ce8cc-6192-4ea1-a948-01d2db55adb6

> FDA 483 for Biomat USA Inc on February 04, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomat USA Inc
- Inspection Date: 2026-02-04
- Product Type: biologics
- Office Name: Denver District Office
- Summary: An FDA inspection of Biomat USA Inc.'s Source Plasmapheresis Collection Center in Surprise, AZ, revealed significant deficiencies. Observations included a failure to maintain complete donor test records, non-adherence to standard operating procedures for donor arm preparation, and an inadequate SOP for investigating adverse donor reactions. These issues highlight concerns regarding data integrity, procedural compliance, and donor safety.

## Related Documents

- [483 - 2026-02-04](https://www.keypedia.com/records/483/biomat-usa-inc/a95351a9-8c03-48b9-acd9-6b91c45df7a6)

## Related Officers

- [Emily S. McGann](https://www.keypedia.com/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)

Company: https://www.keypedia.com/companies/biomat-usa-inc/b5d43046-21da-4980-b8a3-eff18f0059a4

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