# FDA 483 - Suncoast Communities Blood Bank, Inc. - January 31, 2025

Source: https://www.keypedia.com/records/483/suncoast-communities-blood-bank-inc/064ebe54-8ca6-4f70-a6f5-d53e34efb7a6

> FDA 483 for Suncoast Communities Blood Bank, Inc. on January 31, 2025. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Suncoast Communities Blood Bank, Inc.
- Inspection Date: 2025-01-31
- Product Type: biologics
- Office Name: Florida District Office
- Summary: An FDA inspection of Suncoast Communities Blood Bank, Inc. in Bradenton, FL, revealed significant deficiencies across four observations. The firm failed to follow written SOPs for donor deferral, exhibited inadequate personnel training for blood collection, and did not thoroughly investigate product discrepancies. Additionally, the inspection found a failure to submit biological product deviation reports within the required 45-day timeframe.

## Related Documents

- [483 - 2022-07-01](https://www.keypedia.com/records/483/suncoast-communities-blood-bank-inc/885cfc23-f907-4ddb-95e4-58774fd68aea)

## Related Officers

- [Investigator at U.S.FDA](https://www.keypedia.com/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)
- [Nerming V. Briones](https://www.keypedia.com/people/nerming-v-briones/b2d9e685-a627-4f9e-854c-0588865fd1b6)
- [Steen N. Graham](https://www.keypedia.com/people/steen-n-graham/e0ce4c37-b1f1-4d94-8071-2d89b74975fd)

Company: https://www.keypedia.com/companies/suncoast-communities-blood-bank-inc/dabc3b0d-8734-4403-b261-632c56f74dcc

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9