FDA WARNING_LETTER - Invacare Corporation - June 24, 2021

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