Morris Innovative received a six-observation Form 483 for its handling of out-of-specification products, internal audits and corrective and preventive action plans.
The head of quality for the Bloomington, Ind., company conducts all internal audits, including for functions he oversees, according to the Jan. 26 form.
Those functions include complaint handling, CAPA and management reviews. The form also notes that management with executive responsibility had not reviewed the quality system’s effectiveness at set intervals.
The company released product lots with out-of-specification data points, but it had no evidence that it identified, investigated or handled nonconformance the way its process requires. Six out of 11 device history records reviewed during the inspection included OOS data points.
During the inspection, management told the FDA that a testing apparatus had not been validated or qualified, despite the fact that it had been in use since 2007.
Out of 17 complaints received since February 2013, none had evidence of evaluation to determine if an investigation was needed. “Your management explained that it did examine product in inventory but could only produce documented evidence that this occurred for one of the 17 complaints,” the form says.
Morris Innovative could not be reached by press time.