# FDA 483 - Multigon Industries Inc - February 25, 2022

Source: https://www.keypedia.com/records/483/multigon-industries-inc/27e053e2-e07b-4d28-a8dd-d898105f044a

> FDA 483 for Multigon Industries Inc on February 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Multigon Industries Inc
- Inspection Date: 2022-02-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Multigon Industries Inc, a medical device manufacturer in Elmsford, NY, revealed significant deficiencies. The firm failed to maintain written Medical Device Reporting (MDR) procedures, including eMDR and ESG account setup, and did not adequately maintain device history records by lacking supplier identification. These observations indicate serious compliance issues regarding device reporting and record-keeping.

## Related Officers

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

Company: https://www.keypedia.com/companies/multigon-industries-inc/e6cefdb3-72ec-413c-a6e4-cf7d2050818d

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