483
Proven Process Medical Devices, Inc.FDA 483 - Proven Process Medical Devices, Inc. - December 13, 2019
Record Details
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.
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ID · 73890ab3-7d70-4004-8167-ad1d4d61cd80