NDS Surgical Imaging, LLC in Sarasota received a citation from the Food and Drug Administration following a Feb. 13 inspection, according to information posted on the FDA’s website.
The inspection focused on these areas:
- Compliance: Devices
- Postmarket Assurance: Devices
The FDA’s records show the company received a citation for the following issue: ‘Design and development validation was not completed prior to release for use of the product to the customer.’
The FDA regularly inspects facilities throughout the U.S. to confirm product and workplace compliance with federal regulations that aim to safeguard public health. Inspection findings are made available to the public.
The agency’s website states the FDA is responsible for overseeing the safety and quality of human and animal drugs, biological products, medical supplies, and tobacco products.
Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.
