FDA 483 - Biomat USA, Inc. - January 09, 2025

An FDA inspection of Biomat USA, Inc. in Cedar City, UT, revealed significant deficiencies in their operations, particularly concerning plasmapheresis machines and associated documentation. The firm failed to adequately investigate and document equipment failures during qualification, thoroughly investigate discrepancies and unit failures, and maintain concurrent records for machine alerts and alarms. Additionally, the company lacked established standard operating procedures for handling plasmapheresis machines that fail evaluation, indicating a systemic issue with quality control and record-keeping in their source plasma collection processes.