FDA WARNING_LETTER - Mark J. Savant, M.D./San Francisco Research Institute - April 17, 2024

**FDA Warning Letter Summary**

**Company Name:** 2435 Ocean Avenue, San Francisco, CA

**Inspection Dates:** April 9 - April 17, 2024

**Main Violations/Issues:** The FDA inspection revealed significant non-compliance with clinical investigation protocols at the site managed by Dr. Savant. Key violations included failure to adhere to the investigational plan, specifically in calculating the investigational product (IP) dosage based on subjects" body weight, and ensuring subjects met eligibility criteria before enrollment. Notably, a subject received an IP dose calculated for an incorrect body weight, resulting in an overdose. Additionally, subjects were enrolled without meeting required criteria, such as a negative pregnancy test or appropriate risk assessment for progression to hospitalization or death.

**Regulatory Framework:** The violations pertain to non-compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312), which govern clinical investigations and the protection of human subjects.

**Required Actions:** Dr. Savant"s response to the FDA included corrective actions such as reporting protocol deviations to the Institutional Review Board (IRB), ensuring investigators personally handle prescriptions and review source documents, implementing quality checks, and creating detailed checklists for eligibility and visit assessments. Additionally, an onboarding and training plan for site staff was proposed to prevent future violations.

The FDA underscores the responsibility of the clinical investigator to conduct studies in strict accordance with the investigational plan to protect subjects" rights and ensure data integrity. The observed failures raise serious concerns about subject safety and data validity at the site.