FDA 483 - Proven Process Medical Devices, Inc. - December 13, 2019

An FDA inspection of Proven Process Medical Devices, Inc. in Mansfield, MA, a contract manufacturer, revealed significant deficiencies in their quality management system. The firm failed to establish adequate procedures for corrective and preventive actions, control of non-conforming product, and ensure the suitability and maintenance of inspection and test equipment. These observations indicate a need for comprehensive improvements in their manufacturing and quality control processes.