During a bioresearch monitoring inspection on October 15, 2024, the Food and Drug Administration issued seven citations to Pamela K. Den Besten, D.D.S., located in San Francisco, according to data posted on the FDA’s website.
The FDA website indicates that the citations were delivered to the company as follows:
- ‘The immediate package of the investigational new drug does not bear a label with the statement “Caution: New Drug- Limited by Federal (or United States) law to investigational use’
- ‘Failure to provide to an investigator, prior to the start of an investigation, a brochure containing all of the information required by 21 CFR 312.23(a)(5).’
- ‘An investigation was not conducted in accordance with the investigational plan.’
- ‘Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to drug administration and conducting study-related tests.’
- ‘Investigational drug disposition records are not adequate with respect to dates, quantity and use by subjects.’
- ‘Failure to prepare or maintain adequate and accurate case histories with respect to.’
- ‘Not all changes in research activity were approved by an Institutional Review Board prior to implementation.’
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.
