Frequently Recalled Products Increase Risk of FDA Inspection, Agency Says

As the FDA moves forward with its risk-based approach for determining inspection priorities, device manufacturers that produce more frequently recalled products should expect more facility inspections, FDA Senior Recall Coordinator Michael Verdi said.

“You hear about this risk-based inspection process — recalls are part of that formula that goes into how we decide which companies we’re going to inspect maybe more often than others,” Verdi said recently at a Regulatory Affairs Professionals Society meeting.

At the meeting, Verdi listed the top 15 most-recalled devices and said they were the products the FDA will most likely be focusing on when determining inspection priorities. Those product types include: image processing systems-radiological; blood gas measurement; nuclear magnetic resonance imaging; electro-surgical-cutting/coagulation; cardiopulmonary-heart/lung; dialyzers; infusion pumps; catheters (biliary, wire, introducers, percutaneous); fluoroscope X-ray systems; defibrillators; ventilators; accelerators-linear; anesthesia-gas machines; chemical analyzers (clinical uses); and endoscopes.

Along with the FDA’s risk-based approach to facility inspections, the agency’s centers will also play a part in determining which companies the agency will inspect going forward, Verdi said.

To avoid inspections, companies should do everything they can to correct the problems that lead to device recalls, Verdi said.

Verdi noted that the top root cause for device recalls was nonconforming-material components and urged the device industry to spend more time conducting vendor audits. There were 651 recalls for products regulated by the Center for Devices and Radiological Health in fiscal 2006, with 21 Class I, 500 Class II and 130 Class III recalls. Class I recalls are the most serious product corrections and the numbers have increased over the last several years, Verdi said.