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

During an inspection conducted from January 6-9, 2025, the FDA issued a Form 483 to an unspecified firm, highlighting several significant issues related to its operations, particularly concerning plasmapheresis machines and record-keeping, under the regulatory framework of 21 CFR 606.

Key observations included the failure of equipment to perform as designed. Specifically, new plasmapheresis machines (e.g., GA and BY) experienced multiple failures during qualification, such as anticoagulant being out of range, but the firm did not adequately document investigations into the reasons for these failures or ensure repairs were made before the machines were approved for use.

The FDA also noted a failure to thoroughly investigate unexplained discrepancies and units not meeting specifications. Examples included insufficient root cause analysis for an overdraw due to machine malfunction and the improper handling of source plasma units not reclassified for destruction despite lacking required testing.

Furthermore, records were not concurrently maintained, as alerts, alarms, or error messages requiring troubleshooting were not consistently documented in machine electronic logs, nor were actions taken to address them. Finally, the firm lacked established written standard operating procedures for handling instances where plasmapheresis machines fail during evaluation. The firm is required to address these observations to ensure compliance and product quality.