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News Breaks | | | | December 27, 2012 | | 09:18 EDT |  | IVC | Invacare announces workforce reduction at Taylor Street manufacturing facility
Invacare announced that due to a decline in production, the company has initiated an immediate workforce reduction at its Taylor Street manufacturing facility in Elyria, Ohio. The expected decline in production results principally from the company’s previously announced consent decree of injunction with the FDA, which was approved late last week by the United States District Court for the Northern District of Ohio. Invacare currently employs 365 hourly manufacturing associates at its Taylor Street facility in Elyria, Ohio. As a result of the workforce realignment, 222 associates will remain in their current roles or be reassigned to other roles across the Elyria campus. The remaining 143 associates will be laid off. For those associates who have been laid off, Invacare will offer 60 days continuance of pay and benefits. Due to the realignment, the Company expects to incur one-time restructuring charges not to exceed $1.25M on a pre-tax basis. | |
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| May 13, 2013 | | 19:42 EDT | | IVC | Invacare 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. | |
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