# FDA 483 - Temrex  Corporation - June 25, 2021

Source: https://www.globalkeysolutions.net/records/483/temrex-corporation/588d22f4-7831-4d7a-abc8-35620f96a228

> FDA 483 for Temrex  Corporation on June 25, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Temrex  Corporation
- Inspection Date: 2021-06-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Temrex Corporation, a medical device manufacturer and importer in Freeport, NY, revealed significant deficiencies in its quality system. Observations included failures to maintain written Medical Device Reporting procedures and inadequately maintained device history records. Additionally, the firm lacked proper documentation approval for standard operating procedures and failed to establish requirements for suppliers and contractors.

## Related Documents

- [483 - 2025-02-21](https://www.globalkeysolutions.net/records/483/temrex-corporation/9a8b2743-6cda-4771-bb84-38ed7856c5d1)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/temrex-corporation/7cbfbd89-c98d-47c9-a62b-685dd0bb98cc

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