# FDA 483 - Invacare Corporation - June 24, 2021

Source: https://www.globalkeysolutions.net/records/483/invacare-corporation/9d87dc44-0e72-4907-b939-a06039cbae1b

> FDA 483 for Invacare Corporation on June 24, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Invacare Corporation
- Inspection Date: 2021-06-24
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: 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.

## Related Documents

- [483 - 2020-01-31](https://www.globalkeysolutions.net/records/483/invacare-corporation/a24296dc-a57e-486f-a6d6-57cb6343e9cc)
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- [483 - 2025-04-09](https://www.globalkeysolutions.net/records/483/invacare-corporation/6603b819-0c47-443e-8407-efee9db0e202)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)
- [Investigator ](https://www.globalkeysolutions.net/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.globalkeysolutions.net/companies/invacare-corporation/3bcd045d-939b-4887-895f-94ad806383fc

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22