Invacare Corp. has passed a third independent audit related to the U.S. Food & Drug Administration (FDA) consent decree that the manufacturer has been under since December 2012.
The announcement came during a Feb. 11 earnings conference call. In a statement issued after that conference call, Invacare said, “On February 9, 2016, the independent expert auditor issued its certification report for the third phase of the consent decree indicating the company’s substantial compliance with the FDA’s QSR (Quality System Regulations). This report was submitted to the FDA this week.”
The consent decree required Invacare to pass three independent audits. The FDA accepted the manufacturer’s first two audits in 2013.
Before the consent decree can be lifted, the FDA will conduct its own inspection as well, the news statement said: “Per the terms of the consent decree, [Invacare] must submit its own written report to the FDA related to its compliance status together with its written responses to any observations in the independent expert’s report. If and when the FDA accepts the reports of both the independent expert and the company, the [FDA] will re-inspect the impacted facilities.”
The consent decree has limited production at Invacare’s manufacturing facilities on Taylor Street at its Elyria, Ohio, headquarters for several years.
Invacare indicated in its announcement that it cannot estimate whether or not the FDA will decide to accept the manufacturer’s reports, or what additional work the FDA could require Invacare to perform. “However, the company will continue to move forward with continuous improvements to its quality system,” the statement said.
Invacare also announced the hire of John Watkins, who becomes Invacare’s senior VP of quality assurance & regulatory affairs. In announcing Watkins’ appointment, Invacare Chairman, President and CEO Matthew E. Monaghan noted that Watkins has worked for a number of medical device manufacturers and has extensive experience in the quality and regulatory realms.
Watkins replaces Doug Uelmen, who will be leaving Invacare in March.
Monaghan announced that Invacare’s fourth-quarter North American home medical equipment net sales decreased 7.5 percent in 2015 compared to fourth-quarter sales in 2014. The Q4 loss before income taxes in the segment was $6.4 million, compared to a loss of $9.1 million before income taxes in the fourth quarter of 2014.
Invacare said higher fourth-quarter sales of seating & mobility products “were more than offset” by decreases in Invacare’s respiratory and lifestyle product sales.
For 2015, the company reported North American home medical equipment net sales fell 6.6 percent to $474.2 million compared to $507.9 million the year before.
