During a post-market assurance inspection on July 31, 2024, the Food and Drug Administration issued three citations to IRhythm Technologies, Inc., located in San Francisco, according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.’
- ‘Risk analysis is inadequate.’
- ‘Procedures for corrective and preventive action have not been adequately established.’
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety and quality.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
