Medtech Insight is part 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

GE Medical barred from importing x-ray, radiation therapy systems from French facility.

This article was originally published in The Gray Sheet

Executive Summary

GE BARRED FROM IMPORT OF X-RAY, RADIATION THERAPY DEVICES FROM FRENCH FACILITY due to good manufacturing practices deficiencies, FDA says in a June 12 warning letter. GE Medical, which ceased shipments of mammography and radiation therapy systems from the Buc Cedex, France facility on June 24, is working on correcting the deficiencies and plans to respond to the letter by July 3, the firm states. FDA's warning letter followed a Feb. 26-March 6 inspection of the plant.

You may also be interested in...



AMS Acquires Raleigh Adhesive Coatings Company For £22M ($29M) In Cash

Advanced Medical Solutions said it will buy Raleigh Adhesive Coatings for £22m ($29m) in cash to strengthen its overall wound care business. 

Amgen Hands Omecamtiv Back To Cytokinetics

While Amgen said the Phase III GALACTIC-HF results for omecamtiv mecarbil did not meet its high expectations for the heart failure candidate, Cytokinetics sees a path to treating certain patients.

Regeneron COVID-19 Cocktail’s Flame To Burn Brightly But Unclear For How Long

Lilly has launched a similar antibody product, but demand is expected to outpace supply for the foreseeable future.

UsernamePublicRestriction

Register

OM005385

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