FDA 483 - Moldex-Metric, Inc. - May 20, 2022

Moldex-Metric, Inc., a medical device manufacturer in Culver City, CA, was inspected by the FDA. The inspection revealed a significant issue with the lack of documentation for process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for their automated mask molding machines. This indicates a failure to properly record critical manufacturing process parameters and results for Class II medical devices.