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# QS Violations at Invacare Facilities
- URL: https://www.fdaweb.com/qs-violations-at-invacare-facilities/
- Published: 2021-11-30T12:00:00.000Z
- Updated: 2026-09-14T17:24:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150666

FDA 5/25-6/24 inspections at three Invacare manufacturing facilities identified Quality System Regulation violations in the firm’s manufacturing of a variety of Class 2 oxygen concentrators intended for patients with respiratory disorders requiring supplemental oxygen. An 11/18 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/invacare-corporation-617319-11182021?ref=fdaweb.com) says specific violations were: 

- failing to investigate any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications, unless such investigation has already been performed for a similar complaint and another investigation is not necessary;
- failing to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
- failing to establish and maintain adequate procedures for implementing corrective and preventive action, including requirements for using appropriate statistical methodology where necessary to detect recurring quality problems;
- failing to establish and maintain procedures for implementing corrective and preventive actions; and
- failing to submit a report to FDA no later than 30 calendar days after the day that the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that the firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Invacare was told to take prompt action to correct the violations and prevent their recurrence and to respond with a list of specific steps it has taken, with documentation of each step, and a timetable for completing the steps.