# FDA 483 - Biomat USA, Inc - February 11, 2020

Source: https://www.globalkeysolutions.net/records/483/biomat-usa-inc/89c24510-acda-4e21-823c-ce41409e2660

> FDA 483 for Biomat USA, Inc on February 11, 2020. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Biomat USA, Inc
- Inspection Date: 2020-02-11
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Biotest USA, Inc.'s plasmapheresis center in Cincinnati, OH, identified two significant observations. The firm was cited for phlebotomists not adhering to standard operating procedures for arm scrubs, which could compromise the sterility of blood containers. Additionally, the facility failed to provide adequate private space for donor eligibility examinations, leading to donors standing in a crowded waiting area.

## Related Officers

- [Jennifer L. Sheehan](https://www.globalkeysolutions.net/people/jennifer-l-sheehan/a49c628d-6eba-4b52-bafc-70785b9ba75e)

Company: https://www.globalkeysolutions.net/companies/biomat-usa-inc/5468316d-22c2-45ea-919a-4b2a58e3eaf7

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