# FDA 483 - Biomat USA Inc - March 07, 2019

Source: https://www.keypedia.com/records/483/biomat-usa-inc/f8c8757c-7756-4fad-89de-94e1fdad012a

> FDA 483 for Biomat USA Inc on March 07, 2019. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Biomat USA Inc
- Inspection Date: 2019-03-07
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Bio-Blood Components Inc in Columbus, OH, a source plasma establishment, revealed two significant observations. These included inadequate preparation of phlebotomy sites, leading to concerns about sterility, and a failure to timely submit multiple biological product deviation reports. These issues indicate potential non-compliance with regulations concerning donor safety and reporting requirements.

## Related Officers

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

Company: https://www.keypedia.com/companies/biomat-usa-inc/367b61cf-95b5-4528-a735-64e8965299d3

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