Invacare Gets Warning Letter From FDA
December 01 2021 - 9:29AM
Dow Jones News
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.
Invacare (NYSE:IVC)
Historical Stock Chart
From Mar 2024 to Apr 2024
Invacare (NYSE:IVC)
Historical Stock Chart
From Apr 2023 to Apr 2024