FDA 483 - Biomat USA - March 08, 2019

An FDA inspection of BioTest USA, a plasma donor center in Ocala, FL, revealed significant deficiencies across multiple areas. The firm failed to maintain adequate records, including performance qualifications and temperature logs, and did not properly document donor communications. Additionally, BioTest USA was cited for inadequate investigations into unexplained discrepancies like freezer temperature excursions and recurring bleed label mix-ups, and for delays in submitting biological product deviation reports to the FDA.