FDA 483 - Multigon Industries Inc - February 25, 2022

An FDA inspection of Multigon Industries Inc, a medical device manufacturer in Elmsford, NY, revealed significant deficiencies. The firm failed to maintain written Medical Device Reporting (MDR) procedures, including eMDR and ESG account setup, and did not adequately maintain device history records by lacking supplier identification. These observations indicate serious compliance issues regarding device reporting and record-keeping.