New User:

Forgot your password?

Stock Market & Financial Investment News

News Breaks
May 13, 2013
19:42 EDTIVCInvacare reports FDA acceptance of audit related to consent decree
Invacare announced that the United States Food and Drug Administration has found acceptable the company’s first certification audit relating to the qualification and validation documentation for equipment and processes at the Taylor Street manufacturing facility in Elyria, Ohio. This acceptance permits the company’s Taylor Street facility to resume manufacturing and distributing parts, components, accessories and subassemblies to Invacare facilities other than the Taylor Street or corporate facilities, for further manufacturing or to provide service related to medical devices manufactured at those other Invacare facilities. Of the two remaining certification audits, the second audit relating to the company’s design control systems is currently being reviewed by the FDA. Once it receives the FDA's approval on the second certification report, the company may resume design activities, which will enable it to refocus its engineering resources on new product development. The final, third-party certification audit is a comprehensive review of the company's compliance with the FDA's quality system regulation at the impacted Elyria facilities. That audit is underway.
News For IVC From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
There are no results for IVC

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the disclaimer & terms of use