By Michael Dabaie

 

Invacare Corp. said it received a warning letter from the U.S. Food and Drug Administration.

The maker of medical equipment used in non-acute care settings said in a U.S. Securities and Exchange Commission filing that the letter related to observations in a Form FDA-483 issued in June following an inspection of the company's Elyria, Ohio, facilities.

The warning letter relates to procedures involving complaint handling, corrective and preventive action and medical device reporting associated with oxygen concentrators.

The FDA issues a Form 483 at the conclusion of an inspection when an investigator observes any conditions that may constitute violations of the Food Drug and Cosmetic Act and related acts.

Invacare said in the filing it intends to respond in a timely manner and work to adequately address the FDA's concerns.

The company said there has been no impact on the its ability to produce and market its products.

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

December 01, 2021 09:14 ET (14:14 GMT)

Copyright (c) 2021 Dow Jones & Company, Inc.
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