FDA 483 - Tecomet, Inc. - November 12, 2024

An FDA inspection of Tecomet, Inc. in Woburn, MA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, with issues noted in CAPA verification of effectiveness and documentation of extensions. Additionally, the inspection found that document control procedures were not established, leading to the use of uncontrolled forms for cleanroom monitoring logs.