On March 1, 2024, the Food and Drug Administration conducted a bioresearch monitoring inspection of Marcelo V. Negrao, M.D., in Houston, issuing two citations as documented by the FDA, according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.’
- ‘Failure to report non-serious adverse events to the sponsor in accordance with the study protocol timetable for reporting.’
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.
