Unannounced FDA inspections in India, China to begin soon

Regulatory NewsRegulatory News | 15 December 2021 |  By 

An official with the US Food and Drug Administration (FDA) announced the agency will soon resume unannounced onsite inspections in India and China. Also, prioritized foreign inspections will resume in February.
Elizabeth Miller, assistant commissioner for medical products and tobacco operations in FDA’s Office of Regulatory Affairs (ORA), provided this update on the agency’s inspection activities at a 9 December virtual conference on enforcement sponsored by the Food and Drug Law Institute (FDLI). Miller also told industry to expect upcoming inspections to be a hybrid model combining records requests with on-site inspections.
Miller told the webinar that an appropriations bill directs FDA to start a pilot in India and expand it to China for “short unannounced and short-term inspections.” Added Miller, “We are working to build a robust set of evaluations to assess the costs and the benefits and challenges of conducting these inspections. There is more to come on this as we plan to get this started.”
A report from the House Appropriations Committee that accompanied the FY 2021 omnibus bill directed FDA to restart a pilot of unannounced short-term inspections in India and to establish a similar pilot in China. “The Committee is concerned that FDA’s drug inspection program continues to fall behind the levels needed to match the growth in foreign drug manufacturing facilities. The Committee recognizes that FDA’s drug inspection program has responded to the shifting global market by implementing a risk-based approach that prioritizes limited inspection resources, wrote the committee in the report. “However, the Committee notes that FDA’s regular practice of preannouncing foreign drug inspections well in advance of an inspection, raises serious questions about parity with domestic inspections, which are almost always unannounced.”
“While COVID–19 has understandably delayed many routine inspections abroad, the Committee is concerned that FDA may not prioritize physical inspections as highly as other regulatory review methods,” notes a parallel report accompanying as-yet unenacted legislation for FY 2022. The India pilot was originally started in 2014, but shut down in 2015.

Miller said that $3.5 million has been allotted to the pilot and the targeted start date is “early 2022.”
Government officials have been concerned about the pandemic’s toll on FDA’s foreign inspection program. In a March report, the GAO warned a House Appropriations Subcommittee that the agency needs to come up with a plan to address the looming inspection backlog and tackle some of its longstanding issues. (RELATED: FDA’s inspection backlog: GAO raises concern as delays mount, Regulatory Focus 9 March 2021)
Agency resuming prioritized foreign inspections
Also in February, FDA plans to resume prioritized foreign inspections, which are mostly announced. This announcement was made in the agency’s revised resiliency plan. “We are hoping in February that there will be an easing of international travel restrictions and the world will open up,” said Miller.
FDA to conduct more hybrid inspections
Some of the lingering effects of the pandemic will continue to be seen in the enforcement area. For example, Miller told the meeting they should expect to see FDA continue its use of reviewing records in advance of an inspection followed by an onsite inspection.
“You will be seeing more type of hybrid assessments going forward, where you will see record requests followed by inspections…. Going forward, expected to see a lot more of the hybrid approach.”
FDLI enforcement conference


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