Dive Brief
The U.S. Food and Drug Administration has issued a warning letter to iRhythm Technologies after inspectors found fault with practices at a facility that makes its heart monitors.

According to iRhythm, the FDA has alleged “nonconformities to regulations for medical devices, including medical device reporting requirements, relating to the company’s Zio AT System and medical device quality system requirements.”

iRhythm can continue to manufacture and sell its products and does not expect the warning letter to materially affect its financial results. However, the situation comes at a time when iRhythm is working to continue the recent recovery of sales of Zio AT.

Dive Insight
FDA inspectors concluded their assessment of iRhythm’s facility in Cypress, Calif. in August 2022. The FDA visit led to a Form 483 later that month. iRhythm took steps to address the concerns raised in the 483 but its actions failed to stop the FDA from escalating the situation. The FDA sent a warning letter to the company last week, iRhythm said in a filing with the Securities and Exchange Commission. The FDA has yet to publish the notice online.

iRhythm provided a brief overview of the problems identified by the FDA, but full details will only emerge once the letter is published. The company plans to take “appropriate action to further address the 483 observations and other items identified in the warning letter with respect to the Zio AT System.”

Through those actions, iRhythm believes it can resolve the warning letter without suffering a material hit to its financial results. However, the company also warned that until the situation is resolved “additional legal or regulatory action may be taken with or without further notice” and those actions could restrict its ability to sell its Zio AT heart monitors.

The Cypress site is a 34,000 square-foot facility that handles manufacturing and production operations, including inspection, assembly, testing, packaging, labeling, storage and shipping. iRhythm relies on the site to make Zio AT and other products, and expects it to meet its manufacturing needs for at least the next five years.

iRhythm will need to work through the FDA’s concerns without a chief operating officer. Douglas Devine resigned from the position in March, although he will continue as an executive advisor until July 2024. News of the warning letter comes weeks after iRhythm disclosed a U.S. Department of Justice subpoena requesting “various documents” regarding its “products and services.”

The regulatory troubles have hit iRhythm at a time when it is working to continue the recovery of Zio AT, which was hit by operational problems late last year, and grow sales in a market targeted by Philips’ BioTelemetry, Boston Scientific’s Preventice Solutions and Baxter’s Bardy Diagnostics.