FDA Ups Inspections In Foreign Device Manufacturing Facilities
The FDA’s Center for Devices and Radiological Health (CDRH) has released a report revealing 30 percent growth in its number of international inspections between 2013 and 2014, with China at the top of the list. Though this increase is due, in part, to the growing number of facilities in China, experts indicated that mounting concerns regarding quality also played a part in the increase.
In an effort to offer more transparency to device manufacturers who can use the information to ramp up quality control compliance in their own facilities, FDA releases an annual report detailing the number and nature of inspections, warning letters, and Form 483s issued each year.
The 2014 report revealed only a marginal increase in overall inspections, but a 30 percent increase in international inspections, which — according to the report — were more likely to find a violation. Though the number of warning letters has decreased — down to 121, from 144 in 2013 — more than 60 percent of letters issued in 2014 year were issued in foreign countries, and 57 percent of inspections at foreign sites resulted in a Form 483.
“The agency has been working toward increased foreign inspections as foreign manufacturing inventory has been growing rapidly,” said the FDA in the report, adding that “Production and Process Controls [P&PC] and Corrective and Preventative Actions [CAPA] continue to be the most frequently cited QS [Quality System] subsystems.”
In May, Regulatory Affairs Professionals Society (RAPS) reported that the FDA was substantially increasing the number of inspections conducted at foreign generic drug companies, which manufacture 80 percent of drugs prescribed in the U.S. The White House, meanwhile, approved $10 million in additional funds to help increase the number of inspectors on the ground in China, specifically.
The Wall Street Journal cited two agreements calling for regulatory cooperation between the U.S. and China, but noted that problems with the inspectors’ visas were holding up their arrival.
The CDRH conducted 190 inspections in China in 2014, more than double the number conducted in Germany, the next country on the list (72). Bloomberg noted that the number isn’t surprising, given the number of facilities cropping up in China, but companies outsourcing manufacturing to China should make sure to “do more than adequate due diligence” in their foreign-based facilities, stated D.C. lawyer Linda Bentley in the article.
Another D.C. lawyer, Keith Barritt, told Bloomberg that the difference in numbers may only represent a “learning curve” for facilities that are newer to U.S. regulatory standards, and he added, “It’ll be interesting to see if that levels out.”