More Foreign Device Inspections Will Impact Production, Process Controls

More Foreign Device Inspections Will Impact Production, Process Controls


In 2014, CDRH conducted 594 foreign device inspections, almost doubling the number of foreign inspections it conducted the previous year.

An increase in outsourcing is pushing the FDA to conduct more foreign inspections, but it also means that there is more of a disconnect between original equipment manufacturers and suppliers, says Roberta Goode, president of Goode Compliance International.

The majority of the foreign inspections were in China, which aligns with industry trends in recent years of increased offshoring of U.S. manufacturing operations overseas, she said. China had 190 device inspections in 2014 by the FDA.  Number two for FDA inspections was Germany, which saw 72 inspections in 2014, she said, acknowledging data from Dennis Gucciardo, a regulatory affairs legal expert at Hogan Lovells.

Following China and Germany, were Japan, Taiwan, Switzerland, Canada, Ireland, South Korea, the UK and France.

“I’m telling my clients they should be prepared for an increase in inspections in their ex-U.S. operations,” she said.

More Foreign Inspections Means More Production, Process Scrutiny

“And, because those are largely manufacturing sites and not necessarily design centers, they can anticipate more of a focus on their production and process controls, CAPA and related manufacturing elements of the quality system regulation, as opposed to say, design controls, which are primarily in their U.S. design centers,” she told Inspection Insider.

“Once the FDA shows up in one of our foreign facilities, we’ve got to potentially provide support quickly, set up a back room, and send people there,” she said.

Goode reported that of the CDRH warning letters issued so far in 2015, 68.8 percent of the letters that cited QSR nonconformities also cited medical device complaints.

Production and process controls comprised 32 percent of the Form 483 observations in 2014, she said. Corrective and preventive actions were next on the list, which accounted for 31 percent of observations. Design controls were next at 14 percent, management controls at 13 percent and finally, documentation deficiencies accounted for 10 percent of 483 observations.

Goode suspects the reason for the preeminence of production and process controls in 483s is due to a lack of adequate process validation and test method validation.  Companies generally do a poor job of feeding postmarket data back into their risk management programs, and on to their statistical requirements for reliability as encompassed in their process validations.

Adding to this disconnect is the special circumstance of outsourced manufacturing. It’s challenging for original equipment manufacturers to align their process failure modes and effects analysis (FMEA) with companies’ design and use FMEAs and other risk documentation, and update them regularly based on field performance.

Supplier Controls At Center

“Supplier controls are really starting to bubble up to the surface as the next big thing, and it’s because of the disconnect between postmarket data and process validation through the FMEA process, which the supplier often owns if you have an original equipment manufacturer,” Goode said, noting that outsourcing is enhancing “an already-existing disconnect between manufacturers and suppliers.”

She reported that work being done on risk management, through the International Medical Device Regulators Forum, is trying to address some of these shortcomings.

For example, the AAMI/ANSI/ISO 14971 risk management standard is expected to be released soon, which will harmonize how FDA and ex-U.S. regulatory bodies enforce postmarket surveillance through a risk management program that feeds back into verification, validation, design controls, production and process controls and CAPA to address that broken link.

“There’s also a big change in the way the FDA envisions handling complaints and patient harm, which could substantially change the way that device manufacturers will be inspected,” she warned.

Earlier this year, the FDA engaged a multi-stakeholder planning board to develop a national medical device postmarket surveillance system. The agency hired the Brookings Institution to convene the planning board, which came up with recommendations on establishing a national registry that would identify potential safety issues in real-time from a variety of privacy-protected data sources.

“Instead of managing postmarket surveillance after patients are injured, this would use big data and electronic systems to monitor which devices are leading to which problems in which patient populations,” Goode concluded.


[Editor’s note: Roberta Goode will be presenting on Unraveling the Mystery of EU Unannounced Audits at FDAnews’ Inspection Summit, Nov. 4.]

This article was written by Tamra Sami and was published by FDA News’ Inspection Insider.


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