FDA 483 - Precision Metal Products, Inc. - March 26, 2025

An FDA inspection of Precision Metal Products, Inc. in Milford, CT, a contract manufacturer, identified a significant compliance issue related to their quality system. The firm's procedures for device history records were found to be inadequate, specifically lacking requirements for documenting measuring equipment Asset ID numbers during inspections of a Class II medical device. This indicates a need for improved record-keeping and traceability practices.