# FDA 483 - Grifols Biomat, INC - May 11, 2026

Source: https://www.keypedia.com/records/483/grifols-biomat-inc/1cc0e4ba-4e92-4fb8-8e86-e2a15f4aedd0

> FDA 483 for Grifols Biomat, INC on May 11, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Grifols Biomat, INC
- Inspection Date: 2026-05-11
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Grifols Biomat, INC, a plasmapheresis center in Saint Petersburg, FL, was cited by the FDA for a significant failure to maintain donor records. The inspection revealed that the firm was unable to provide donor records from January 2023 to April 2026, which included adverse reaction investigations for multiple donors. This indicates a serious deficiency in the facility's record-keeping practices.

## Related Officers

- [Steen N. Graham](https://www.keypedia.com/people/steen-n-graham/e0ce4c37-b1f1-4d94-8071-2d89b74975fd)

Company: https://www.keypedia.com/companies/grifols-biomat-inc/a3a68850-9bb0-4a84-8121-c29b3a23c3f9

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6