Biomat USA, Inc – FDA 483, Sep 13, 2023

Biomat USA, Inc, a Class II medical device manufacturer in City Of Industry, CA, was inspected by the FDA from September 11-13, 2023. The inspection identified a significant deficiency related to the firm's failure to develop written procedures for Medical Device Reporting (MDR). This indicates a critical gap in their quality system regarding the handling and reporting of adverse events.