Invacare Corp.'s quality control system still isn't up to par.
Federal regulators once again found a long list of problems during a lengthy inspection at the medical equipment company's Elyria, Ohio headquarters.
None of those problems sound all that scary on their own.
Together, however, they show that Invacare has yet to fix some of the issues that forced the company to shut down almost all manufacturing operations at its plant on Taylor Street three years ago, according to regulatory experts who spoke with Crain's.
The list of problems includes some “pretty big misses” that Invacare should have taken care of by now, according to Ray Ursick, principal consultant at Matrix Medical Devices in Cleveland.
The problems noted by the U.S. Food and Drug Administration are fixable, but “it's going to take a lot of work for Invacare to get out of this,” Ursick said.
So what did the company miss? For one, the report starts by noting that Invacare deviated from the consent decree issued by the FDA in December 2012 — the one that forced the company to overhaul its quality control system.
What did it do wrong? When the FDA inspection began in July, Invacare had yet to identify all the products that needed to go through a process called design remediation.
On Aug. 28, it provided a list of 21 power wheelchairs and power beds that still needed to go through the process, which involves re-evaluating the methods used to design and test a product, as well as the documentation processes that ensure those methods are properly followed.
Deviating from a consent decree might not look good from the FDA's perspective, according to Stephanie Harrington, founder of Matrix Medical.
“You're not doing what you told us you would do. How do we have any confidence that you're going to be able to fix the rest of it?”
Harrington estimates that it would take three to six months to fix the violations listed in the report, which fills just over 11 pages.
And that doesn't include the time it will take Invacare to prove to the FDA that these sorts of mistakes won't keep happening.
The inspection lasted 71 days, stretched out over five months. Its goal was to determine whether Invacare was living up to changes it said it would make following two third-party audits it completed in 2013.
Even if Invacare had aced the inspection, the FDA still wouldn't have lifted the consent decree: The company has spent a few years trying to pass a third audit designed to analyze its entire quality control system. Once that audit is complete, the FDA will conduct another inspection before deciding whether to lift the decree — and give Invacare the go-ahead to ramp up manufacturing at its Taylor Street plant.