FDA 483 - Biomat USA Inc - January 28, 2026

Biomat USA Inc, a plasmapheresis center in Cleveland, OH, was cited for failing to consistently follow its written standard operating procedures during an FDA inspection. Specifically, the firm did not adhere to its procedure for completing Donor Adverse Events Reports, leading to discrepancies in onset times and inconsistencies between digital and printed records. This indicates a breakdown in procedural compliance for critical donor event documentation.