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

An FDA inspection of Polymer Corporation, a contract manufacturer in Middletown, CT, revealed a significant deficiency in their quality management system. The firm failed to adequately control nonconforming product, specifically by not being able to locate documentation for two external nonconformances related to a Class II medical device. This indicates a breakdown in their established procedures for managing product quality.