# FDA 483 - TruCore Distributors Inc - March 10, 2020

Source: https://www.keypedia.com/records/483/trucore-distributors-inc/fe33e001-b06c-4c85-b600-d6aa406a1a6b

> FDA 483 for TruCore Distributors Inc on March 10, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TruCore Distributors Inc
- Inspection Date: 2020-03-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: TruCore Distributors Inc, a medical device relabeler in Kings Park, NY, was cited for a significant deficiency related to its quality system. The inspection revealed a lack of written procedures for electronic Medical Device Reporting (eMDR), specifically for handling incidents involving serious injuries and death. This indicates a critical gap in the firm's ability to report adverse events as required.

## Related Officers

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

Company: https://www.keypedia.com/companies/trucore-distributors-inc/5ed52f90-f705-4c80-aefe-b21f7ba3c4c7

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