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

Biomat USA, Inc. in Cedar City, UT, a source plasma firm, was cited for significant deficiencies related to equipment qualification, deviation investigations, record-keeping, and standard operating procedures. The inspection revealed failures to document investigations for malfunctioning plasmapheresis machines, incomplete documentation for discrepancies, and a lack of procedures for equipment failures. These issues indicate a systemic breakdown in quality control and record management practices.