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

Source: https://www.keypedia.com/records/483/premium-plus-dental-supplies-inc/09d941de-271e-456c-b877-471dc553ecae

> FDA 483 for Premium Plus Dental Supplies Inc. on October 18, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Premium Plus Dental Supplies Inc.
- Inspection Date: 2019-10-18
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

## Related Officers

- [Gregson A Joseph](https://www.keypedia.com/people/gregson-a-joseph/90bf8118-3f32-4f44-95c4-fcde1f741a18)
- [Preston M. Lee](https://www.keypedia.com/people/preston-m-lee/e44adac3-a915-4bfb-8b06-a41ea5803358)

Company: https://www.keypedia.com/companies/premium-plus-dental-supplies-inc/10ddf72e-ac41-4a46-8926-22c031d2b219

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961