U.S. FDA Adding Staff at India, China Offices

The U.S. Food and Drug Administration expects to boost its China office staff to 35 within the next two years and its India staff to 23 as the agency focuses on increasing inspections in both countries.

The agency’s China office currently boasts 12 Americans and two local staffers, said Leigh Verbois, incoming director of the China office. Growing the office has been hampered by a Chinese visa process that could take up to two years, but that has recently been cut to just weeks, she told a session at the DIA annual meeting June 16 in Washington, D.C.

Meanwhile, the FDA’s India office is set to grow from 12 agency and four local staffers to 19 Americans and four locals, said Matthew Thomas, acting country director.

The FDA’s offices in India and China conduct preannounced and unannounced inspections, but are focusing on the preannounced visits to build confidence with local drugmakers and educate them about FDA regulations.

Earlier this year, Indian officials accused FDA investigators of conducting unannounced inspections of drug manufacturers without Indian inspectors present (IPRM, February). The FDA denied the allegations, saying it was working on plans to incorporate Indian investigators into the inspection process.
— Jonathon Shacat

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