FDA 483 - Prototype & Plastic Mold Company, Inc. - January 10, 2025

An FDA inspection of Polymer Corporation, a contract manufacturer located in Middletown, CT, was conducted from January 8-10, 2025. During this inspection, the FDA issued a Form 483, detailing observations of conditions and practices that indicate potential deviations from regulatory requirements. The primary observation noted was that the company's procedures for controlling nonconforming product were not adequately established or followed. Specifically, the firm’s Quality Manager was unable to locate and provide documentation for two external nonconformance reports (NCR# 19150 & 19151) related to a Class II medical device. These NCRs were logged in the company’s system, but the supporting records, which are required by the firm's own 'Quality Management Procedure for Control of Nonconforming Product' (QMP-023, Rev. 9), could not be retrieved. This observation highlights a deficiency in maintaining complete and accessible records for nonconforming products, which is a critical component of a robust quality management system under the Federal Food, Drug and Cosmetic Act. Polymer Corporation is expected to review these findings, identify the root causes, and implement comprehensive corrective and preventive actions to ensure proper control and documentation of all nonconforming products, thus demonstrating compliance with FDA regulations. The firm has indicated a promise to correct this observation.