US FDA Looks To Resume Unannounced Inspections In India And China

Dec 13 2021

• By Shannon Brown

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After lapsing due to COVID-19, an unannounced foreign inspection pilot program is on track to resume in 2022, “despite challenges and constraints of travel.”

US FDA ramping up inspections in China and India • Source: Alamy

The US Food and Drug Administration will be resuming a program to perform unannounced and short-notice inspections of drugs and facilities in India and will be expanding the program to China, according to the FDA’s Elizabeth Miller. Miller is the Assistant Commissioner of Medical Products and Tobacco Operations at FDA’s Office of Regulatory Affairs, and oversees the FDA’s inspectorate.

Speaking at the Food and Drug Law Institute Enforcement, Litigation, and Compliance Conference on 9 December, Miller said that the...

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