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

MITSUBISHI ELECTRIC JAPANESE LINEAR ACCELERATOR FACILITY

This article was originally published in The Gray Sheet

Executive Summary

MITSUBISHI ELECTRIC JAPANESE LINEAR ACCELERATOR FACILITY will be reinspected by FDA on May 24 to determine whether an agency ban on the import of equipment manufactured at the site should be lifted. The inspection of the facility in Amagasaki City, Hyogo, Japan will assess the firm's corrections of good manufacturing practices deficiencies that were observed by FDA during a July inspection and that led to the import alert for all the facility's products ("The Gray Sheet" Nov. 30, p. 11). Although FDA will wait to lift the ban until it reviews the results of the May inspection, the agency recently allowed U.S. imports of certain components of Mitsubishi's linear accelerators. The components are being used to retrofit 55 linear accelerators in the field under a corrective action plan (CAP). The company says that FDA allowed the firm to begin shipping the parts and making field corrections in February even though the agency has not officially approved the CAP. According to Mitsubishi, the components modify the linear accelerator's beam "interlock system." The company maintains that the device has not presented any risks to patients, and it has been informing customers on a monthly basis to operate their linear accelerators according to directions outlined in the operator's manual. The firm expects that FDA will deem the field correction a Class II recall. Mitsubishi has received three warning letters related to the linear accelerator facility. After a hospital in Gary, Indiana complained about problems with the EXL 14 accelerator, the agency issued two warning letters to the firm and placed the EXL 14 on import alert ("The Gray Sheet" June 15, p. 16). FDA's third warning letter was issued after the July inspection. The letter listed the findings that led the agency to expand the import alert to all devices manufactured at the Amagasaki City plant.
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT000413

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