FDA WARNING_LETTER - Maria W. Greenwald, M.D. - October 27, 2022

The FDA issued a Warning Letter to Dr. Greenwald following an inspection from October 17-27, 2022, which reviewed clinical investigations under Protocols (b)(4) and (b)(4). The inspection, part of the Bioresearch Monitoring Program, identified significant violations of 21 CFR Part 312, governing clinical investigations and human subject protection.

**Key Violations:**

1. **Failure to conduct investigation according to the investigational plan [21 CFR 312.60]:** * **Ineligible Subject Enrollment:** Dr. Greenwald enrolled subjects who did not meet eligibility criteria, including concurrent enrollment in mutually exclusive studies (Protocols (b)(4) and (b)(4)) and enrolling subjects with exclusionary medical conditions (e.g., inflammatory arthritis in Protocol (b)(4)). * **Prohibited Medication Use:** Subjects were enrolled despite recent participation in other systemic medication studies within prohibited timeframes, and some used prohibited concomitant medications (e.g., (b)(4) in Protocol (b)(4)). One subject was continued on a medication (b)(4)) to which they had a documented inadequate response, contrary to protocol. The site continued subjects on prohibited medications even after awareness. * The FDA deemed the site's October 31, 2022, response inadequate, stating explanations were factually incorrect or lacked supporting documentation.