Invacare receives feedback from FDA
ELYRIA, Ohio – Invacare has received observations from the FDA following an inspection of its corporate headquarters and Taylor Street manufacturing facility. “The FDA’s inspection included a review of the company’s compliance with terms of the consent decree, including requirements of the first and second certifications previously reviewed and accepted in 2013,” the company stated in an 8-K Form dated Dec. 9. Invacare is planning a response to the FDA. “The company remains focused on developing a strong enterprise-wide quality culture,” it stated in the form. “It will incorporate the FDA’s observations into its ongoing quality systems improvements.” Invacare is still in the process of trying to complete a third and final audit* to comply with FDA regulations. The consent decree with the FDA limits the company’s ability to manufacture and sell custom power wheelchairs and seating systems.