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FDA Inspected 739 (26%) of Non-U.S. Drug Sites

FDA says it inspected 26% (739) of the 2,852 foreign-based human drug manufacturing sites outside of the U.S. in fiscal year 2018. In a 5/17 agency post, FDA provided a glimpse into its recent drug inspection activities. “As of fiscal year 2018, there were 4,676 human pharmaceutical sites worldwide subject to routine surveillance inspection — 61% of those were foreign-based,” the post says. “For that year, the FDA conducted 1,365 human drug Current Good Manufacturing Practice (CGMP) surveillance inspections, of which 739 were conducted at facilities outside the U.S., to ensure manufacturers were following CGMP requirements and maintaining high quality standards.”


The agency recently has had to defend its oversight of the generic drug industry following media reports that have questioned their quality and safety (see earlier story). “By maintaining global vigilance over the generic manufacturing industry, in close collaboration with our international regulatory partners, FDA provides confidence in the quality of these medicines while helping patients realize more of the benefits from high quality, low cost generics,” the agency post says. “Through Program Alignment, coordination with FDA’s Center for Drug Evaluation and Research and Office of Global Policy and Strategy, as well as more global partnerships, we can continue to take enhanced steps to address the increasing challenges posed by a global supply chain and encourage the adoption of new advanced manufacturing methods. These actions are key parts of our commitment to ensure high-quality manufacturing, and to make sure Americans have confidence in the quality of products in their medicine cabinets — regardless of where they were manufactured.”


FDA notes that in the two years since Program Alignment began, agency investigators have a greater focused expertise across all products that fall under FDA’s purview, and its “regulation of generic drugs has never been stronger, more strategic, more risk-based, or more efficient than it is today.”

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