# FDA 483 - Temrex  Corporation - February 21, 2025

Source: https://www.keypedia.com/records/483/temrex-corporation/9a8b2743-6cda-4771-bb84-38ed7856c5d1

> FDA 483 for Temrex  Corporation on February 21, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Temrex  Corporation
- Inspection Date: 2025-02-21
- Product Type: device
- Office Name: New York District Office
- Summary: Temrex Corporation, a manufacturer in Freeport, NY, was cited for a significant deficiency in its complaint handling system during an FDA inspection. The firm failed to adequately maintain complaint files, specifically its Customer Complaint Matrix Form, which lacked essential information such as UDI codes, complainant contact details, complaint nature, and replies to complainants. This indicates a breakdown in their quality system for managing customer feedback.

## Related Documents

- [483 - 2021-06-25](https://www.keypedia.com/records/483/temrex-corporation/588d22f4-7831-4d7a-abc8-35620f96a228)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d