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483
•BioLife Plasma Services LP•December 16, 2021

BioLife Plasma Services LP – FDA 483, Dec 16, 2021

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
View Company Profile

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

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