OOS Products, Internal Audits Cited in Morris 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.

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.

The form also called out CAPA issues. For example:

• Verification of effectiveness is not required in the company’s CAPA or nonconforming product procedures. One CAPA on tip protectors dislodging was closed in February 2013 without evidence of verification. Another CAPA was opened in November 2013 for the same issue but the company took a different corrective action;
• One CAPA was opened more than two months after a complaint on failure of the CB hub during a surgery. This was about seven weeks after a second complaint for the same issue; and
• CAPA and nonconforming product procedures do not discuss analysis of sources of quality data.

According to the form, Morris’ management “confirmed that it has not recently conducted such analysis of data.”

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. The Form 483 is available at www.fdanews.com/06-28-16-Morris.pdf. — April Hollis