FDA 483 - PMT Corporation - February 15, 2024

PMT Corporation, a medical device manufacturer in Chanhassen, MN, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish corrective and preventive action procedures, did not timely investigate numerous customer complaints, and maintained inadequate risk analysis documents for its sEEG Depthalon depth electrodes. Additionally, the inspection revealed that equipment calibration procedures were not routinely followed, with several pieces of production equipment found to be overdue for calibration.