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.”