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In Law360, Attorneys Analyze Developments with Unannounced FDA Inspections of Foreign Facilities

Practices: FDA Regulatory, Life Sciences Licensing, Collaborations & Joint Ventures, Health Care, Biomedical Research: Human, Animal and Bench Science, Risk Management Industries: Healthcare & Life Sciences

In a Law360 article, life sciences regulatory & compliance partner Joshua Oyster, counsel Beth Weinman and associate Chadli Pittman examined the U.S. Food and Drug Administration (FDA) pilot program to restart an unannounced foreign drug inspection in India and establish an additional pilot in China, two locations collectively encompassing more than one-third of the foreign drug establishments supplying the U.S. market.

The article describes the background leading up to the creation of the new pilot program, outlines the unique enforcement risks facing foreign drug manufacturers, and offers suggestions for inspection readiness.

The authors note that while it is not possible to know what firms will appear on the FDA's unannounced inspection list, foreign drug manufacturing facilities should consider the relative ease with which the FDA can issue an import alert to prevent products made in facilities with subpar manufacturing practices from entering the U.S. market.

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