FDA 483 - Biomat USA Inc - December 09, 2025

Biomat USA, Inc. in Zanesville, OH, a source plasmapheresis center, received a Form 483 with four observations. The inspection revealed significant issues including failures in ensuring sterile plasma separation, maintaining accurate quality control records, adhering to manufacturer instructions for reagent handling, and following written standard operating procedures for blood component collection. These observations indicate deficiencies in critical aspects of plasma processing and quality assurance.