Hi Tech Mold & Tool, Inc. – FDA 483, Jun 11, 2026

Hi Tech Mold & Tool, Inc. in Pittsfield, MA, a medical device manufacturer, received a Form FDA 483 for significant deficiencies in process validation. The firm failed to validate production processes for multiple product codes and manufacturing equipment, and a performance qualification did not meet established targets. These issues indicate a lack of adequate control over critical manufacturing processes.