# FDA 483 - Suncoast Communities Blood Bank, Inc. - July 01, 2022

Source: https://www.globalkeysolutions.net/records/483/suncoast-communities-blood-bank-inc/885cfc23-f907-4ddb-95e4-58774fd68aea

> FDA 483 for Suncoast Communities Blood Bank, Inc. on July 01, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Suncoast Communities Blood Bank, Inc.
- Inspection Date: 2022-07-01
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Suncoast Communities Blood Bank, Inc. in Bradenton, FL, a community blood center, revealed a significant failure to thoroughly investigate unexplained discrepancies. This included issues with an insufficient number of product quality control samples tested and an inaccurate monitoring system for collected units and completed samples. These findings indicate a breakdown in the firm's quality system for ensuring product quality and data integrity.

## Related Documents

- [483 - 2025-01-31](https://www.globalkeysolutions.net/records/483/suncoast-communities-blood-bank-inc/064ebe54-8ca6-4f70-a6f5-d53e34efb7a6)

## Related Officers

- [Investigator at U.S.FDA](https://www.globalkeysolutions.net/people/barbara-t-carmichael/4c451805-e327-450d-b2e5-48a40f6232fe)
- [Lura Baquero](https://www.globalkeysolutions.net/people/lura-baquero/55dc6eb5-01d5-427e-a3ef-cc6ca35f3837)
- [FDA_PERSONNEL](https://www.globalkeysolutions.net/people/edward-a-brunt/f823f6cb-7fb1-422b-b022-cb0d673f6210)

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

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