The Food and Drug Administration (FDA) issued two citations to Oral Iq, LLC in West Hollywood following an inspection on February 23, 2024, which evaluated post-market assurance for devices, according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘The design review results, including identification of the design, the date and the individual(s) performing the review, were not documented in the design history file.’
- ‘Procedures for design transfer 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.
