Tag: FDA Consent Decree

ELYRIA, Ohio ­- Invacare looks forward to re-introducing providers to a “different company” now that it has the green light to resume full operations at its corporate headquarters and Taylor Street facilities.The U.S. Food and Drug Administration notified Invacare in a letter dated July 24 that the company has satisfied requirements under a consent decree that has limited its ability to make and sell products from the facilities for nearly five years, since December 2012.“When I...

ELYRIA, Ohio - Now that Invacare has made significant progress toward lifting a consent decree with the U.S. Food and Drug Administration, it's paving the way to launch a robust pipeline of new products later this year, company officials told analysts during an earnings call May 9.In the first half of 2017, Invacare expects continued lower net sales—offset by favorable sales mix and increased gross margin as a percent of net sales—but by the end of the year, it expects a “sustainable...

ELYRIA, Ohio - The U.S. Food and Drug Administration will now pick back up on a third and final certification report submitted by Invacare's third-party auditor.The FDA on April 13 notified Invacare that it has accepted an updated second certification report submitted by the company's third-party auditor, allowing it to resume design activities at its corporate headquarters and Taylor Street manufacturing facilities in Elyria.“It's good to have this milestone, but there's more work ahead,”...

ELYRIA, Ohio - Invacare posted first quarter losses last week, but if you look at the company as a “long-term turnaround,” you'll see some short-term improvements, says top exec Matthew Monaghan.Invacare reported a net loss of $8.6 million for the first quarter of 2016 compared to a net loss of $7.3 million for the same quarter last year. It reported net sales of $257.6 million vs. $289 million.For North America HME, which has been hardest hit by a consent decree with the U.S. Food and...

ELYRIA, Ohio - There is little update on Invacare's final audit to comply with U.S. Food and Drug Administration (FDA) regulations, other than to say it's in progress, according to a conference call on April 24.During the call to discuss Invacare's first quarter earnings for 2014, President and CEO Gerry Blouch said he couldn't predict when the audit, the company's third and the most comprehensive, would be completed.“All audits can be viewed as a three-step process: is the process as designed...

ELYRIA, Ohio - A “small number” of employees are returning to Invacare's Taylor Street facility, according to a story by the Chronicle-Telegram. Per a consent decree put in place by the U.S. Food and Drug Administration (FDA) in December 2012, the company limited design, manufacturing and distribution activities at the plant, resulting in the layoff of 236 employees. Returning employees are being placed throughout the facility, according to the story. “It's a small number, but I...