During a bioresearch monitoring inspection on February 16, 2024, the Food and Drug Administration (FDA) issued three citations to Americo F. Padilla, M.D., based in Miami, according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘Permission by parents or guardians for the participation of children as subjects in a clinical investigation was not documented in accordance with and to the extent required by 21 CFR 50.27.’
- ‘An investigation was not conducted in accordance with the signed statement of investigator and investigational plan.’
- ‘Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation.’
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.
