# FDA 483 - Dentorium Products Co. Inc. - July 30, 2019

Source: https://www.globalkeysolutions.net/records/483/dentorium-products-co-inc/8aec3ab2-0221-4281-808b-9b7a33782352

> FDA 483 for Dentorium Products Co. Inc. on July 30, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dentorium Products Co. Inc.
- Inspection Date: 2019-07-30
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Dentorium Products Co. Inc., a medical device importer and repackager in Farmingdale, NY, identified one observation. The firm failed to maintain adequate written Medical Device Reporting (MDR) procedures. This indicates a significant deficiency in their quality system regarding adverse event reporting.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.globalkeysolutions.net/companies/dentorium-products-co-inc/f2664e13-c3fa-4d48-8f94-40a7f5e8b5cd

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