Invacare Must Do More Work At Ohio Plant: FDA

FDA has given Invacare information on additional steps the company must take to meet design control requirements at its Taylor Street facility in Elyria, OH. The company reported in an SEC filing that FDA clarified its requirement for Invacare to complete the remediation of certain design history files referenced in the FDA-483 that followed a 2015 agency inspection at the facility and in a consent decree between the agency and the company. “Before the company can design any new Taylor Street wheelchair devices,” the filing says, “the specified design history files must be completed, then recertified by the company’s third-party expert, whose updated report must be accepted by FDA. FDA also has clarified that its acceptance of the expert’s updated report on these design history files is a prerequisite to proceeding further with the third certification process.”