Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Warning Letter Roundup & Recap – March 13, 2018

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.

Advertisement

Related Content

Manufacturers Enter The Competitive Online Market For Contact Lenses
FDA Warning Letters For Olympus, Fujifilm, Pentax: Duodenoscope-Makers Fail To Meet Agency's Post-Market Surveillance Study Order

Topics

Advertisement
UsernamePublicRestriction

Register

MT122338

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel