FDA 483 - Temrex Corporation - February 21, 2025

During an inspection conducted by the Food and Drug Administration (FDA) from February 11-21, 2025, Temrex Corporation, a manufacturer located in Freeport, NY, received a Form FDA 483. This document outlines observations made by the FDA investigator indicating conditions that may not comply with regulatory requirements for medical devices. The primary observation noted was that the company's complaint files are not adequately maintained.

Specifically, Temrex Corporation's Customer Complaint Matrix Form No. 7501 Rev. A lacked essential details for documented customer complaints. The missing information included the Unique Device Identification (UDI) code for the device involved, complete contact information for the complainant (name, address, and phone number), a detailed description of the complaint and the device's relation to the reported problem, and any response provided to the complainant. These findings suggest deficiencies in the company's quality system regarding complaint handling. While the FDA 483 itself is not a final determination of non-compliance, it necessitates a thorough review and implementation of corrective actions by Temrex Corporation. The company has indicated a commitment to correct the identified issues, which is essential for demonstrating adherence to regulatory expectations.