Invacare takes steps to get out from under FDA

Invacare ($IVC) has been hamstrung by an FDA consent decree, halting production at an Ohio plant, but the company is moving back toward normalcy, completing the first of three audits.

With the agency's blessing, Invacare can now resume producing parts, components, accessories and subassemblies at its Elyria, OH, facility. The FDA is currently reviewing Invacare's second audit, which, if approved, will allow the company to get back to design activities.

The third and most comprehensive audit, under way now, is to ensure Invacare is in keeping with the FDA's Quality System Regulation, and Invacare can't resume full operation at the facility until it is approved. Invacare expects to wrap up a third-party inspection and submit the results to the FDA later this quarter.

Invacare doesn't know just when it will be able to resume full-scale manufacturing at the plant, but the initial clearance is a move in the right direction for the beleaguered manufacturer, which slashed 143 jobs at the facility when the FDA first took action in December.

"This is an important step forward for the company in demonstrating its quality systems compliance to the FDA,'' CEO Gerald Blouch said in a statement. ''I am incredibly proud of the Invacare team and all of the work that they have put into improving our quality systems. This is the first critical step in resuming full production at the Taylor Street manufacturing facility.''

But the regulatory problem has already hampered Invacare's bottom line. In the first quarter, sales fell 4.9% to $337.6 million, and the company posted a $4.5 million net loss after pulling in $5.6 million in profits in 2012's Q1. In January, Invacare closed a deal to send its growing medical supplies business to AssuraMed for $150.8 million, planning to pay down debt and fund its FDA-guided remediation with the proceeds.

- read Invacare's statement

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