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Tag: consent decree


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Invacare reduces workforce

December 8, 2017HME News Staff

ELYRIA, Ohio - Invacare will reduce its workforce by about 110 employees to generate $8.5 million in pre-tax savings, the company announced Dec. 7.The move, which affects employees in North America, is part of a multi-year strategic plan to transforms Invacare into a more clinically focused company, says Matthew Monaghan, chairman, president and CEO.“This reduction in force, while difficult, is an essential part of the second phase of our transformation toward becoming a more sustainably profitable,...

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Vendors

Invacare looks to hire again

October 26, 2017HME News Staff

ELYRIA, Ohio - After a consent decree with the U.S. Food and Drug Administration forced Invacare to reduce its workforce a number of times in the past few years, the company is ready to hire again.Invacare is hosting a job fair today at its corporate headquarters, with an eye toward hiring workers skilled in computer numerical control, welding, assembly, sewing and machine operation, according to The Chronicle Telegram.Invacare's Lara Mahoney told the local newspaper that the company is looking to...

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Invacare looks to stabilize in second half of 2017

August 8, 2017HME News Staff

ELYRIA, Ohio - Invacare reported $233.5 million in net sales for the second quarter of this year compared to $275 million for the same period last year, a 15.1% decrease.For the North America/HME business segment, it reported $77.7 million in net sales compared to $110.7 million, an 86.4% decrease.“As indicated previously, we expected net sales to continue to decline through the first half of 2017 before stabilizing sequentially later in the year,” said Matthew Monaghan, chairman, president...

consent decree, financial results, Invacare, turnaround


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Vendors

FDA lifts Invacare's consent decree

July 25, 2017HME News Staff

ELYRIA, Ohio - Invacare has the green light to make and sell products again from its Taylor Street manufacturing facility and corporate headquarters here, the company announced July 25.A consent decree with the U.S. Food and Drug Administration has limited Invacare's ability to make and sell products from the facilities for nearly five years, since December 2012.“Invacare can design, manufacture, process, pack, repack, label, hold, distribute, import into or export from the United States, the...

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Invacare clear for re-inspection

April 28, 2017HME News Staff

ELYRIA, Ohio - Invacare has completed the final milestones required to lift a consent decree with the U.S. Food and Drug Administration, paving the way for a re-inspection, the company announced April 27.“The re-inspection is an important step before the company may resume full operations at the impacted facilities,” Invacare stated in a press release.The decree has limited Invacare's ability to manufacture and sell certain products from its corporate headquarters and Taylor Street facilities...

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Invacare can resume design activities

April 18, 2017HME News Staff

ELYRIA, Ohio - Invacare has been given the green light to resume design activities, according to a Form 8-K filed with the Securities and Exchange Commission.On April 13, the U.S. Food and Drug Administration accepted a recent second certification report submitted by Invacare's third-party expert relating to design control requirements at its corporate headquarters and Taylor Street manufacturing facilities in Elyria, Ohio.“The company is pleased to have achieved this milestone and believes...

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Invacare shifts into phase two of transformation

February 10, 2017Liz Beaulieu, Editor

ELYRIA, Ohio - 2016 was the year Invacare tore itself down and 2017 will be the year it starts building itself back up, Matt Monaghan said during a conference call Feb. 9 to discuss the company's fourth quarter and year-end financial results.In 2016 and especially in the fourth quarter, Invacare saw the impact of significant costs from investing in the North America sales forces, quality remediation, and research and development—ahead of expected benefits, said Monaghan, chairman, president...

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Invacare earnings show signs of 're-orientation'

February 9, 2017HME News Staff

ELYRIA, Ohio - Invacare has reported net sales of $264.7 million for the fourth quarter of 2016 compared to $283.3 million for the same period in 2015. It reported net losses of $17.6 million vs. $2.93 million. Invacare reported net sales of $1.05 billion for 2016 compared to $1.14 billion for 2015. It reported net losses of $42.86 million vs. $26.45 million. “Compared with 2015, which was better for cash flow and operating income, our 2016 results show the near-term impact of the investments...

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Vendors

Change of focus drives improvements at Invacare

August 5, 2016Liz Beaulieu, Editor

ELYRIA, Ohio - Invacare is holding tight to an improvement in gross margin for its beleaguered North America HME division as a sign that its turnaround efforts are paying off.The company saw an increase in gross margin as a percentage of net sales of 2.5 percentage points in the second quarter this year compared to the same period last year. Driving that improvement: increases in net sales for mobility and seating products, which make up the majority of its clinically complex portfolio, an emerging...

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Invacare readies to submit final report to FDA

February 12, 2016HME News Staff

ELYRIA, Ohio - Invacare could be turning the corner on its “ongoing journey” to lift a consent decree with the Food and Drug Administration that has handicapped the company since late 2012.An independent auditor on Feb. 9 issued its certification report for the third phase of the decree, indicating Invacare's substantial compliance to the FDA's quality system regulation or QSR, Matt Monaghan, chairman, president and CEO, announced during a Feb. 11 conference call to discuss fourth quarter...

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