Invacare releases update on third certification report relating to FDA consent decree.
Invacare Corp. officials announced that, while it has made significant progress on the final third-party expert certification audit relating to the quality systems at its corporate and Taylor Street manufacturing facilities in Elyria, Ohio, it has recently received additional input from the third-party expert.
In a release, the company noted that this input has clarified that some additional work is required in a few particular areas before the final certification report can be provided to the United States Food and Drug Administration (FDA). The final third-party certification audit is a review of the company's compliance with the FDA's Quality System Regulation (QSR) at the impacted Elyria facilities. The company has already completed two third-party expert certification audits, and the FDA has found the results of both to be acceptable. In the first two audits, the third-party expert certified that the company's equipment and process validation procedures and its design control systems were compliant with the FDA's QSR.
At a meeting on Friday, December 20, 2013, the third-party expert indicated that its remaining observations from the final certification audit are largely focused on the sustainable compliance of the company's updated complaint and risk review processes. As part of the remediation, the company conducted an overhaul of its complaint handling system. This change has led to an increase in the backlog of complaints, as the updated procedure now requires the funneling of all sources of complaint data through one system. The launch of this new process initially outpaced the company's ability to add and train new associates to thoroughly address and conduct standard investigations of complaint data. This backlog, combined with the breadth of Invacare's product offerings and the complexity associated with its highly configurable medical devices, provided a challenge to the company's ability to investigate and close complaints in a timely manner, classify and code the issues when complaint data provided to the Company is not complete and demonstrate consistent use of the risk review process.
The new complaint handling system has been operating for several months, and the company has been closing significantly more complaints than are opened. The company has added additional contractors to further expedite clearing the backlog in order to achieve and demonstrate sustainable improvement.
"We are formalizing an action plan to address the observations of the third-party expert, who we would expect to return in February to commence their re-audit of the quality system. While we are disappointed that the final certification report is not ready to be filed, we have made significant progress in our quality systems improvements over the past two years. Notwithstanding our extension of the timeline resulting from the complexities of this process, the fact remains that our associates have done an incredible amount of work. We remain fully committed to meeting the expectations of our third-party auditor and ultimately the FDA, so we can return to full operations at our corporate and Taylor Street manufacturing facilities," said Gerald B. Blouch, president and chief executive officer.
At this point, the company cannot predict the timing of the completion of the third-party's final certification report. However, when the expert's final certification report is completed and submitted to the FDA, along with the company's own report as to its compliance as well as responses to any observations in the certification report, the FDA will inspect the company's corporate and Taylor Street facilities to determine whether they are in compliance with the FDA's QSR. The FDA has the authority to reinspect these facilities at any time. Once satisfied with the company's compliance, the FDA will provide written notification that the company is permitted to resume full operations at the impacted facilities.
The company will provide an update on the consent decree process in its year-end earnings release.
Source: Invacare Corp.