Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

Menu

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
My View
Tags:
Medical Device Regulation Compliance

Warning Letter Roundup & Recap – November 24 & December 1, 2015

This article was originally published in The Gray Sheet

  • News

Executive Summary

Manufacturer WalkMed dinged for problems with its Triton infusion pumps, and the firm distributed potentially flawed Triton FP pumps; Panoramic Rental didn't report a field correction to FDA after it asked customers to add a warning sticker to its dental X-ray machines; and more. Three device warning letters were listed by FDA last week; one was listed this week.

Table

View full table

Topics

Tags:
Medical Device Regulation Compliance
Latest Headlines

Vivalink Partners With Rett Syndrome Research Trust To Accelerate Research In Rare Disease

Small Sterilization Companies Poised To Meet EtO Emissions Goals On Time

At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use

UK MHRA Updates Assistive Tech And Borderline Regulations

See All
UsernamePublicRestriction

Register

MT034428

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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

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