483
Biomat USA IncFDA 483 - Biomat USA Inc - May 09, 2024
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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.
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ID · f4112897-d210-400e-a226-bd945b302ded