FDA 483 - Vaupell Molding and Tooling, Inc. - March 06, 2020

Vaupell Molding and Tooling, Inc. in Agawam, MA, a medical device contract manufacturer, was cited with two observations during an FDA inspection. The inspection revealed deficiencies in the firm's process validation activities, which were not documented or approved for a Class II medical device accessory. Additionally, process control procedures were found to be inadequately established, lacking proper identification of part numbers and assembly instructions for the medical device accessory.