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483
•Suncoast Community Blood Bank Inc•April 13, 2022

Suncoast Community Blood Bank Inc – FDA 483, Apr 13, 2022

Record Details

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.

Company
Suncoast Community Blood Bank Inc
Inspection date
April 13, 2022
Product type
biologics
Office
Office of Medical Device and Radiological Health Division II
Person
  • Amanda B Vega
View Company Profile

ID · d44dcffd-320a-40bc-964d-19fa5f18f7d6

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