FDA 483 - Biotest Pharmaceuticals Corporation

An FDA inspection of Biotest Pharmaceuticals Corporation's plasmapheresis center in Hinesville, Georgia, revealed significant deficiencies in donor qualification and record-keeping. The firm failed to consistently perform required serologic tests for syphilis and serum protein electrophoresis on initial donor samples, leading to the collection of unsuitable plasma units. Additionally, discrepancies were found in manufacturing records regarding the lot numbers of supplies used for plasma collections, raising concerns about product traceability and data integrity.