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Warning Letters FDA Enforcement

Warning Letter Roundup & Recap – March 13, 2018

  • News
  • Shawn Schmitt
    Shawn M. Schmitt

Executive Summary

Duodenoscope-makers Olympus, Fujifilm and Pentax Medical failed to conduct post-market surveillance study activities mandated by US FDA in 2015; quality systems violations noted at firms that make dental diagnostic X-ray devices and laser fiber-optic surgical devices. Six device-related warning letters were released by the agency this week.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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