FDA 483 - Biomat USA Inc - May 09, 2024

An FDA inspection of BioTek America LLC, a plasmapheresis center in Nacogdoches, TX, identified a significant issue regarding regulatory reporting. The firm failed to submit a biological product deviation report within the required 45 days for distributed plasma units from donors screened with incorrect gender-specific questionnaires. This indicates a lapse in compliance with reporting requirements for reportable events.