# FDA 483 - Biomat USA Inc - January 28, 2026

Source: https://www.keypedia.com/records/483/biomat-usa-inc/97856239-0af2-4bd5-9c07-ab3d9b4dbf5c

> FDA 483 for Biomat USA Inc on January 28, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomat USA Inc
- Inspection Date: 2026-01-28
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: Biomat USA Inc, a plasmapheresis center in Cleveland, OH, was cited for failing to consistently follow its written standard operating procedures during an FDA inspection. Specifically, the firm did not adhere to its procedure for completing Donor Adverse Events Reports, leading to discrepancies in onset times and inconsistencies between digital and printed records. This indicates a breakdown in procedural compliance for critical donor event documentation.

## Related Officers

- [Nancy L. Neiger](https://www.keypedia.com/people/nancy-l-neiger/c3209528-eeb3-4a5f-88b1-f503798ed4c5)

Company: https://www.keypedia.com/companies/biomat-usa-inc/2d97f6ea-eda7-46ea-a392-ad3c58a66386

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22