The Food and Drug Administration (FDA) cited Diagnostic Consulting Network, LLC in Carlsbad for 2 violations during a device compliance inspection carried out on March 13, according to data available on the FDA’s website.
According to the FDA website, the company received the following citations:
- ‘The document control procedure does not adequately define controls needed to review and approve documents for adequacy before use and ensure that current versions of applicable documents are available at point of use.’
- ‘Records of risk management activities in product realization were not adequately maintained.’
The FDA regularly inspects facilities around the United States to evaluate whether businesses and their products adhere to FDA regulations that aim to safeguard public health. Results of these inspections are shared publicly.
The FDA states on its website that it is responsible for overseeing the production and distribution of drugs for humans and animals, biological products, medical devices, and tobacco goods to ensure safety and quality.
Information in this article was gathered from the U.S. Food and Drug Administration. The source data is available here.
