FDA 483 - Invacare Corporation - January 31, 2020

The FDA issued a Form 483 to Invacare Corporation, a medical device manufacturer in Elyria, OH, following an inspection from January 13 to January 31, 2020. The observations detail significant deficiencies in the company's quality system, primarily concerning its purchasing controls, document change management, and corrective and preventive actions. Regarding purchasing controls, the FDA found Invacare's procedures for ensuring product and service conformity inadequate, citing issues like supplier evaluation limits not based on risk, neglected packaging testing for certain medical devices, inconsistent documentation of supplier criticality, and unclear processes for approving supplier plans and reports. The firm also failed to perform required audits for some key suppliers. Additionally, Invacare lacked sufficient controls over document changes. The inspection revealed incomplete documentation for changes to approvers and insufficient explanations for the reasons and impacts of various document updates, including those affecting supplier monitoring and medical device reporting criteria. The "Impact Analysis" procedure was also deemed inadequate for assessing effects on prior decisions. Finally, the report highlighted deficiencies in corrective and preventive action documentation. Specifically, a Class II recall initiated due to a patient injury from a faulty patient lift lacked proper verification, validation, and effectiveness checks for the implemented corrective measures. These observations indicate potential non-compliance with the Federal Food, Drug, and Cosmetic Act's quality system requirements for medical device manufacturers. Invacare is expected to implement comprehensive corrective actions to address these systemic issues, as indicated by their promise to correct each observation.