# FDA 483 - Biomat USA Inc - December 09, 2025

Source: https://www.keypedia.com/records/483/biomat-usa-inc/ec367322-217f-47ed-83de-fe06a3f85225

> FDA 483 for Biomat USA Inc on December 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: 2025-12-09
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: Biomat USA, Inc. in Zanesville, OH, a source plasmapheresis center, received a Form 483 with four observations. The inspection revealed significant issues including failures in ensuring sterile plasma separation, maintaining accurate quality control records, adhering to manufacturer instructions for reagent handling, and following written standard operating procedures for blood component collection. These observations indicate deficiencies in critical aspects of plasma processing and quality assurance.

## Related Officers

- [Nisha C. Patel](https://www.keypedia.com/people/nisha-c-patel/1b38764f-c7bc-4f90-9af1-54989ad6d59c)

Company: https://www.keypedia.com/companies/biomat-usa-inc/31d92ad7-c601-4193-b6e3-5d49cf0f191d

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