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FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk

March 9, 2018Drug Recalls & Safety Notices, Drug Safety Information Podcasts, Food & Drug Recalls, Food Safety Newsadmin

FDA has issued warning letters to Olympus, FujiFilm and Pentax, for failing to comply with section 522 orders on postmarket surveillance studies for duodenoscopes

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← Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. House Committee on Energy and Commerce Subcommittee on Oversight and Investigations hearing “Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza.” Starwest Botanicals Inc. Product Recalls Organic Cardamom Pods Green (Whole) Due to Possible Salmonella Contamination →
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