FDA 483 - Pamela K. Den Besten, DDS - October 15, 2024

Pamela Den-Besten, DDS, a Sponsor-Investigator in San Francisco, CA, was cited for significant deficiencies during an inspection of her clinical trial. The inspection revealed multiple failures related to human subject protection, including inadequate informed consent, deviations from the investigational plan, and lack of IRB approval for critical study changes. Additional violations involved improper investigational drug labeling, insufficient record-keeping, and inadequate drug accountability.