FDA WARNING_LETTER - Amy Lightner, MD - April 26, 2023

This Warning Letter, CBER-25-682593, dated March 25, 2025, informs Dr. Lightner of objectionable conditions observed during an FDA inspection from April 3, 2023, to April 26, 2023, regarding clinical investigations (b)(4). The inspection, under the Bioresearch Monitoring (BIMO) Program, identified violations of 21 CFR Part 312.

Key violations include: 1. **Failure to conduct investigations according to the signed investigator statement, investigational plan, and applicable regulations (21 CFR § 312.60):** * **Eligibility Criteria:** Subjects were dosed with investigational product (IP) before required eligibility screening tests were completed, including for out-of-town subjects. The proposed checklist for eligibility is recommended to be completed at least 24 hours prior to IP administration. * **Adverse Event (AE) Recording and Reporting:** Serious Adverse Events (SAEs) for subjects (b)(4) were not recorded and reported to the IRB as required by the protocols. Specifically, subject (b)(6)'s hospitalization was not documented as an SAE. * **DSMB Reporting:** Safety/adverse event data, including SAEs like a surgical procedure for participant (b)(6), were not sent to the Data and Safety Monitoring Board