483
ABO Holdings IncFDA 483 - ABO Holdings Inc
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Record Details
ABO Holdings, Inc., a plasmapheresis center in San Diego, California, was cited for two significant observations during an FDA inspection. The firm failed to correctly perform Performance Qualification studies for centrifuges by using incorrect assay values. Additionally, the firm did not test subsequent donations from donors who previously tested reactive for relevant transfusion transmitted infections (RTTI).
- Company
- ABO Holdings Inc
- Product Type
- Biologics
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ID · 612c3b3e-533b-45f6-b108-0dd015bd9913