# FDA 483 - Huron Tool & Cutter Grinding Co - December 05, 2023

Source: https://www.keypedia.com/records/483/huron-tool-cutter-grinding-co/351e8efa-84a5-4656-818f-7bd0b251e900

> FDA 483 for Huron Tool & Cutter Grinding Co on December 05, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Huron Tool & Cutter Grinding Co
- Inspection Date: 2023-12-05
- Product Type: other
- 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 significant deficiencies in the documentation of corrective and preventive action (CAPA) activities. The firm failed to adequately document several CAPA reports, specifically lacking justifications for completion timelines and verification sections. This indicates a moderate level of non-compliance with quality system documentation requirements.

## Related Documents

- [483 - 2021-07-09](https://www.keypedia.com/records/483/huron-tool-cutter-grinding-co/6fe8b21f-2d2e-4c6d-a1d6-5b8259d13176)

## Related Officers

- [Andrew J. Garufi](https://www.keypedia.com/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

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

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