FDA 483 - Biomat USA Inc - April 04, 2023

Talecris Plasma Resources Inc, a plasmapheresis center in Lafayette, LA, was cited for two observations during an FDA inspection. The firm failed to ensure that a contracted laboratory performing FDA-required testing for Relevant Transfusion-Transmission Infection (RTTI) maintained an active CLIA certification. Additionally, the firm did not conduct a thorough investigation after being informed that the testing laboratory's CLIA certification had expired, continuing to send blood samples for testing.