BioLife Plasma Services LPDecember 16, 2021

FDA 483 - BioLife Plasma Services LP - December 16, 2021

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Record Details

An FDA inspection of BioLife Plasma Services LP in Jacksonville, FL, revealed two significant observations. The facility failed to ensure donor privacy during health history screenings and did not maintain sterile conditions during phlebotomy site preparation. These issues indicate potential risks to donor confidentiality and product sterility.

Company: BioLife Plasma Services LP
Inspection Date: December 16, 2021
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Division II
Person: Amanda B Vega

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ID · 518cb17d-31c2-4b29-987b-6a15a3d4e644