FDA 483 - Invacare Corporation - June 24, 2021

Invacare Corporation, a medical device manufacturer in Elyria, OH, received an FDA Form 483 citing multiple significant deficiencies during an inspection. The observations primarily concern inadequate complaint handling and investigation procedures, failure to submit Medical Device Reports for serious malfunctions, and weaknesses in corrective/preventive actions. The firm also demonstrated issues with statistical data analysis and document control related to product recalls.