# FDA 483 - Suncoast Community Blood Bank Inc - April 13, 2022

Source: https://www.keypedia.com/records/483/suncoast-community-blood-bank-inc/d44dcffd-320a-40bc-964d-19fa5f18f7d6

> FDA 483 for Suncoast Community Blood Bank Inc on April 13, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Suncoast Community Blood Bank Inc
- Inspection Date: 2022-04-13
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Suncoast Community Blood Bank Inc in Sarasota, FL, revealed deficiencies in phlebotomy site preparation procedures. Observations included an employee failing to complete a targeted swab step and experiencing significant delays between preparation steps, as well as an employee contaminating sterile gauze with non-sterile gloves. These issues indicate a failure to ensure maximum assurance of a sterile container of Whole Blood.

## Related Officers

- [Amanda B Vega](https://www.keypedia.com/people/amanda-b-vega/9629eae7-acd3-4d4a-b456-a9427b525efb)

Company: https://www.keypedia.com/companies/suncoast-community-blood-bank-inc/cad01f41-bc7d-4c10-9621-b16f89eb0f84

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