FDA 483 - Temrex Corporation - February 21, 2025

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.