Premium Plus Dental Supplies Inc.October 18, 2019

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

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Record Details

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.

Company: Premium Plus Dental Supplies Inc.
Inspection Date: October 18, 2019
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
People: Gregson A Joseph
Preston M. Lee

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ID · 09d941de-271e-456c-b877-471dc553ecae