B Positive National Blood Services

FDA 483 - B Positive National Blood Services

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Record Details

B Positive National Blood Services, a plasmapheresis center in Egg Harbor Township, New Jersey, was cited for failing to adequately test blood donations for relevant transfusion transmitted infections (RTTI). Specifically, the firm did not test subsequent donations from donors who had previously tested reactive for RTTIs, such as HCV, due to samples not being shipped to the testing laboratory. This indicates a serious lapse in ensuring the safety of blood products.

Company: B Positive National Blood Services
Product Type: Biologics
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Barbara G. Peoples

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ID · 860d6183-2f3f-4276-b0d3-e6cd02837845