# FDA 483 - Huron Tool & Cutter Grinding Co - July 09, 2021

Source: https://www.globalkeysolutions.net/records/483/huron-tool-cutter-grinding-co/6fe8b21f-2d2e-4c6d-a1d6-5b8259d13176

> FDA 483 for Huron Tool & Cutter Grinding Co on July 09, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Huron Tool & Cutter Grinding Co
- Inspection Date: 2021-07-09
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Huron Tool & Cutter Grinding Co in Farmingdale, NY, revealed a significant compliance issue regarding Medical Device Reporting (MDR) procedures. The firm failed to maintain written MDR procedures and did not register for the FDA Electronic Submissions Gateway (eMDR) system, which is required for submitting reports of serious injuries and deaths. This indicates a lapse in critical post-market surveillance and reporting requirements for a medical device manufacturer.

## Related Documents

- [483 - 2023-12-05](https://www.globalkeysolutions.net/records/483/huron-tool-cutter-grinding-co/351e8efa-84a5-4656-818f-7bd0b251e900)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/huron-tool-cutter-grinding-co/4b17e91f-c3d2-4c6a-9d88-6237464c3779

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