Morris Innovative Lands Six-Item Form 483

Morris Innovative received a six-observation Form 483 for its handling of out-of-specification products, internal audits and CAPA issues.

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 OOS 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. — Tamra Sami