FDA 483 - Premium Plus Dental Supplies Inc. - October 18, 2019

An FDA inspection of Premium Plus Dental Supplies Inc., an importer and initial distributor in Brooklyn, NY, revealed a significant deficiency in their Medical Device Reporting (MDR) procedures. The firm failed to maintain written MDR procedures that specify reporting malfunctions contributing to death or serious injury. This indicates a moderate severity issue related to regulatory compliance for medical device reporting.