During an FDA inspection on January 19, 2024, SensiMedical, LLC, located in Miami, was issued a single citation related to post-market device assurance, as reported by the FDA, according to data posted on the FDA’s website.
The FDA website shows that the company was cited for the following problem: ‘The design history file was not 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.
