In a Form 8-K filed with the SEC yesterday, iRhythm said it received the warning letter on May 25. The warning letter resulted from an FDA inspection at the company’s Cypress, California facility that concluded on August 2022.
The warning letter alleged that iRhythm was not conforming to medical device reporting requirements related to its Zio AT and medical device quality system requirements, according to the company’s SEC filing. (The actual letter is not yet available on the FDA’s website.)
Said iRhythm: “The company takes these matters very seriously. The company intends to respond within the specified time period and work diligently to address the FDA’s concerns.”
IRTC shares were down more than 6% to $113.94 apiece by midday trading today. MassDevice’s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was down slightly.
More about FDA’s warning letter to iRhythm
As part of the response to an FDA Form 483 received on Aug. 12, 2022 (“483 observations”), iRhythm has already taken corrective actions intended to address certain items identified by the FDA, according to the SEC filing. Now that it’s received a warning letter, iRhythm plans to take further appropriate action to address the FDA’s 483 observations and other items identified in the warning letter with respect to the Zio AT system.
iRhythm also said: “The warning letter does not directly restrict the manufacture, production or shipment of any of the company’s products in the United States or require the withdrawal of any product from the U.S. marketplace. At this time, the company believes that its receipt of this warning letter, without further adverse action initiated by the FDA, will not have a material impact to the company’s financial results”
However, the company also said it could give assurances that the FDA would be satisfied with its responses — or that the FDA might take further action in the future that would materially impact the company.
The warning letter report comes weeks after iRhythm’s first-quarter earnings report, in which it disclosed its third subpoena in more than two years from federal investigators. The news raised some questions from analysts, who were otherwise positive about the quarterly results. iRhythm said at the time that it was too early to speculate on the nature or timing of the inquiry.
