# FDA 483 - Biomat USA, Inc. - July 07, 2021

Source: https://www.keypedia.com/records/483/biomat-usa-inc/a49556f4-9a54-4572-9e28-b4b70cab7e17

> FDA 483 for Biomat USA, Inc. on July 07, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biomat USA, Inc.
- Inspection Date: 2021-07-07
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Biomat USA, Inc. in Wichita Falls, TX, was cited on a Form 483 for failing to follow its written standard operating procedures during an inspection from June 30 to July 7, 2021. The firm implemented a new electronic donor management system without completing a required performance qualification. This oversight resulted in donors donating plasma more frequently than permitted, thereby posing a health risk to the donors.

## Related Officers

- [Elmina E Akwo](https://www.keypedia.com/people/elmina-e-akwo/ecd9066d-1647-4765-ad86-dbe5280241c5)

Company: https://www.keypedia.com/companies/biomat-usa-inc/edbd4f55-9776-4416-82ee-1a5c4aa49b2a

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