# FDA 483 - Biomat USA Inc - May 09, 2024

Source: https://www.globalkeysolutions.net/records/483/biomat-usa-inc/f4112897-d210-400e-a226-bd945b302ded

> FDA 483 for Biomat USA Inc on May 09, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomat USA Inc
- Inspection Date: 2024-05-09
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of BioTek America LLC, a plasmapheresis center in Nacogdoches, TX, identified a significant issue regarding regulatory reporting. The firm failed to submit a biological product deviation report within the required 45 days for distributed plasma units from donors screened with incorrect gender-specific questionnaires. This indicates a lapse in compliance with reporting requirements for reportable events.

## Related Officers

- [Michelle Paxon](https://www.globalkeysolutions.net/people/michelle-paxon/1748c593-7d85-4ede-a5f4-8c0a33c21d52)

Company: https://www.globalkeysolutions.net/companies/biomat-usa-inc/e4fc91a3-6344-4d94-ae7b-76696273cee6

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab