FDA finds safety issues at overseas drug plant supplying U.S. medications

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After years of concern, the FDA has inspected a Glenmark Pharmaceuticals facility in India linked to a number of U.S. drug recalls and patient deaths. The plant was found to produce pills that often failed to dissolve properly, posing potential health risks. During the inspection, officials found problems with cleaning and quality testing processes, issues they said could directly impact the safety of medicines shipped to American consumers. Although many drugs used in the U.S. are manufactured abroad, reports have repeatedly warned that the FDA lacks enough inspectors to effectively monitor these international factories.

Source

Cuddy, E., Lu, Y. P., & Ridley, D. B. (2023). FDA Global Drug Inspections: Surveillance Of Manufacturing Establishments Remains Well Below Pre-COVID-19 Levels. Health affairs (Project Hope), 42(12), 1758–1766. https://doi.org/10.1377/hlthaff.2023.00686

Additional Reading

https://www.propublica.org/article/glenmark-pharmaceuticals-recalls-fda-inspection#:~:text=The%20Food%20and%20Drug%20Administration,eight%20deaths%2C%20federal%20records%20show.

https://www.medpagetoday.com/publichealthpolicy/fdageneral/113362

https://www.nbcnews.com/health/health-care/how-tainted-drugs-get-market-make-sick-patients-sicker-n954786