FDA to Begin Pilots Aimed at Enhanced Enforcement at Foreign Drug Facilities

FDA plans to begin a pilot in 2022 on unannounced foreign inspections of foreign drug facilities, in response to concerns that facilities in China and India are able to fix problems before announced inspections to evade FDA enforcement, according to a GAO report released Feb. 7. Likewise, the agency also will soon run a pilot on use of independent translators for inspections in China and Hong Kong, rather than relying on translators provided by the inspected facility.

Both pilots will test whether the use of unannounced and short-notice inspections and independent translators will improve FDA enforcement or result in a difference in compliance findings. FDA’s domestic facility inspections are almost always unannounced, the report said. FDA officials said “preannouncing inspections can make it more challenging for investigators to observe the true day-to-day operating environment of an establishment during an inspection,” GAO said. Agency investigators also are concerned about the accuracy of information they get from translators provided by foreign establishments.

According to the GAO report, foreign inspections of about 16% of inspected drug facilities found deficiencies serious enough to warrant regulatory action in fiscal years 2018 through 2020 -- “official action indicated,” in FDA’s terminology -- while about 17% of domestic facilities found such issues. In terms of raw number of inspections, 14.3% of inspections in China resulted in an OAI finding, 14.6% in India, and 11.2% domestically. In contrast, 8.9% of inspections of Canadian facilities resulted in OAI, 3.1% in Japan and 1.3% in Germany.

While the pilots have been planned for several years, the COVID-19 pandemic has delayed the plans, GAO said. The report recommended FDA “incorporate leading practices into the design” of both pilots.

GAO also expressed concerns with FDA’s staffing for foreign inspections. As of November 2021, eight of 20 positions were vacant in the agency’s cadre of drug investigators who conduct only foreign inspections, and five of 15 drug investigator positions were vacant in offices located in China and India. While FDA noted that inspections were up in the months prior to the pandemic, after declines in inspections in fiscal years 2016 and 2018, GAO said FDA needs to develop strategies to recruit and retain a sufficient foreign inspection workforce to meet its foreign inspection goals.