FDA 483 - Kem Medical Products Corp - January 15, 2020

Kem Medical Products Corp, a medical device manufacturer in Farmingdale, NY, was cited for two observations during an FDA inspection. The firm failed to maintain written Medical Device Reporting (MDR) procedures, specifically lacking electronic MDR procedures for serious injuries and deaths. Additionally, complaint files were not adequately maintained, as the firm did not use its designated form to document consumer complaints since 2016.