During an FDA inspection on December 11, 2024, Dharma Research, Inc., based in Miami, was issued three citations related to post-market assurance for medical 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 results of design validation, including identification of the design, method(s), the date and the individual(s) performing validation, were not documented in the design history file.’
- ‘Corrective and preventive action activities and/or results have not been documented.’
- ‘The device history record does not demonstrate that the device was manufactured in accordance with the device master record.’
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.
