FDA 483 - Peter Michael, M.D. - June 11, 2024

The FDA conducted an inspection of Peter Michael, M.D., a clinical investigator at GfC Research Group in Hialeah, FL, from June 3 to June 11, 2024. The inspection revealed significant compliance issues with investigational protocols. Key violations included the failure to adhere to the investigational plan, where three out of eleven subjects were overdosed with an investigational product, receiving 12mL instead of the prescribed dose, leading to adverse events such as nausea and headaches. Additionally, there was a failure to maintain adequate case histories, with ten out of twelve subjects having unassessed laboratory reports due to delayed processing and lack of access by Dr. Michael to the laboratory portal. Furthermore, missing source documents for one subject were noted, including vital records and lab requisition forms.

These observations were made under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act, which mandates the reporting of objectionable conditions that could render a product unsafe. The FDA requires corrective actions to address these deficiencies, including ensuring adherence to investigational plans, maintaining comprehensive case histories, and ensuring all necessary documentation is complete and accessible. Dr. Michael is advised to discuss any objections or corrective actions with the FDA and submit relevant information to the agency.