FDA 483 - Huron Tool & Cutter Grinding Co - July 09, 2021

An FDA inspection of Huron Tool & Cutter Grinding Co in Farmingdale, NY, revealed a significant compliance issue regarding Medical Device Reporting (MDR) procedures. The firm failed to maintain written MDR procedures and did not register for the FDA Electronic Submissions Gateway (eMDR) system, which is required for submitting reports of serious injuries and deaths. This indicates a lapse in critical post-market surveillance and reporting requirements for a medical device manufacturer.