During an inspection on August 21, 2024, the Food and Drug Administration (FDA) issued two citations to Knox Medical Diagnostics, Inc., located in San Francisco, for issues related to device compliance, according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘The results of the evaluation of each event are not documented and maintained in the manufacturer’s MDR event file.’
- ‘Records of complaint investigations do not include required information.’
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.
