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Nov. 5 — The FDA's most recent data on inspectional observations and warning letter citations issued to medical device manufacturers, posted on the agency's website Nov. 4, showed an increasing focus on foreign-based facilities, particularly in China.
The report, “2014 Annual FDA Medical Device Quality System Data,” was issued by the Center for Devices and Radiological Health (CDRH). It shows a steady increase in the number of international inspections performed by the agency, with China topping the list of locations.
The number of foreign quality system surveillance inspections rose to 594 in 2014 from 460 in 2013, with 190 inspections occurring in China, the report said. Germany was next on the list for calendar year 2014, with 72 inspections, followed by Japan with 37.
In similar data the agency released last year, Germany topped the list, with China coming in second (8 MELR 672, 10/15/14).
And with regard to foreign-based companies, the data from 2008 to 2014 revealed that the agency has found a higher percentage of foreign-based device manufacturers—58 percent—not fully compliant with the FDA's Quality System Regulation (QSR)—compared to 48 percent of domestic manufacturers. The QSR governs FDA inspections of medical device manufacturing facilities.
Attorney Sonali Gunawardhana, of Wiley Rein LLP in Washington, told Bloomberg BNA Nov. 5 that the data also show that foreign inspections are more likely to result in some type of QSR violation than are domestic inspections.
And “some of that discrepancy may be explained by the learning curve for foreign manufacturers,” attorney Keith Barritt, of Fish & Richardson P.C. in Washington, said.
“It will be interesting to see if that levels out,” Barritt told Bloomberg BNA Nov. 5.
The data bear out the agency's increased international focus.
Although the total number of routine medical device quality system surveillance inspections has remained relatively steady from 2010 to 2014, the percentage of foreign inspections has steadily increased. In 2011, there were 341 inspections of foreign companies compared with 594 international inspections in 2014, according to information in the report.
While China accounted for more than 30 percent of all international inspections in 2014, attorney Linda D. Bentley, of Mintz, Levin Cohn, Ferris, Glovsky and Popeo, P.C. in Boston, told Bloomberg BNA that figure isn't surprising, given the large number of facilities there. “It's probably just a drop in the bucket,” she said.
Bentley said that because the FDA now has an office in China, the agency is likely to be able to inspect Chinese facilities more regularly than in the past. Nevertheless, she said, the agency focus on China also may relate to overall quality concerns.
“My sense is the FDA is concerned about quality issues coming out of China,” Bentley said. Accordingly, device firms that are outsourcing manufacturing to China should make sure they do “more than adequate due diligence” on those facilities, she said.
And with regard to the types of QSR violations most frequently cited by the FDA, attorneys say the most recent data is consistent with data the agency published in the past.
The QSR includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing and servicing medical devices intended for human use.
The two quality system areas that are most heavily reviewed and cited by the FDA in inspections—corrective and preventive action (CAPA) violations, and production and process controls (P&PC)—were also the top areas most frequently cited in the agency's data for recent years, Bentley told Bloomberg BNA. “So my advice about quality system issues would be the same as in the past,” she said.
“Things are pretty much status quo in the world of QSR inspections,” Gunawardhana agreed. “The big area remains inadequate CAPAs across the board for both domestic and foreign facilities.”
Edward C. Wilson Jr., of Hogan Lovells US LLP in Washington, also said the FDA is continuing to find companies falling short in the same areas. “P&PC and CAPA continue to be areas where FDA is finding a lot of perceived noncompliance,” Wilson told Bloomberg BNA Nov. 5. “Neither of those are big surprises but industry should be aware of them,” he said.
The FDA issued the report, which includes FDA Form 483 (inspectors' observations) and warning letter citations, in connection with its Case for Quality Initiative (8 MELR 647, 10/1/14). The initiative also seeks to enhance the transparency of quality-related data for devices.
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