# FDA WARNING_LETTER - Invacare Corporation - June 24, 2021

Source: https://www.globalkeysolutions.net/records/warning_letter/invacare-corporation/932f3372-9d8b-4357-9b99-e2e829194e1c

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

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## Details

- Record Type: WARNING_LETTER
- Company Name: Invacare Corporation
- Inspection Date: 2021-06-24
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: The FDA issued a Warning Letter to Invacare Way following an inspection from May 25 to June 24, 2021, at their medical device operations in Elyria, OH. The inspection revealed that Invacare, a manufacturer of Class II Oxygen Concentrators, failed to conform to Quality System regulation (21 CFR Part 820), rendering their devices adulterated under section 501(h) of the Act.

Key violations include:
1. **Failure to investigate complaints (21 CFR § 820.198(c)):** Invacare did not investigate approximately 10% of Oxygen Concentrator complaints (2,589/25,777) between February 2020 and April 2021, particularly for devices past their end-of-life or component wear period, or when component failure was assumed due to wear. The firm's responses and corrective actions (CAPA CA-00067) were deemed inadequate as the updated procedure still doesn't require investigations regardless of injury/death.
2. **Inadequate complaint procedures (21 CFR § 820.198(a)):** The "Customer Feedback and Complaint Entry" procedure (WI-CP14-002-022) inadequately assigns severity scores for harms like hypoxia, leading to devices not being returned for investigation when

## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/joseph-s-matrisciano/62ff5cd6-c3ab-4443-bf26-f61a512f3960)
- [Office Director](https://www.globalkeysolutions.net/people/malvina-b-eydelman/3b4d6cfe-2cb5-42fb-9d60-a1c7f2300f60)

Company: https://www.globalkeysolutions.net/companies/invacare-corporation/ce6ef1ad-105f-4eb0-b2a1-46530b41907a

Office: https://www.globalkeysolutions.net/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7