FDA WARNING_LETTER - Richard J. Obiso, PhD dba Avila Herbals, LLC - July 26, 2021

The FDA issued a Warning Letter to Dr. Obiso and Avila Herbals, LLC, following an inspection from July 12 to July 26, 2021. The inspection reviewed Avila Herbals' role as sponsor and Dr. Obiso's role as clinical investigator for the clinical investigation of the investigational drug (b)(4) (Protocol (b)(4)).

The FDA identified several objectionable conditions and violations of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 312:

1. **Failure to submit an Investigational New Drug (IND) application (21 CFR 312.20(a), 312.20(b), and 312.40(a)):** The investigational article (b)(4) was determined to be a "drug" and a "new drug" under the FD&C Act, intended to cure, mitigate, treat, or prevent disease, including COVID-19. Avila Herbals initiated the clinical investigation, enrolling (b)(4) human subjects, without an approved IND or qualifying for an IND exemption. 2. **Failure to assure IRB review and approval (21 CFR 312.66):** Dr. Obiso failed to ensure that an Institutional Review Board (IRB) complying with 21 CFR Part 56 was responsible for the initial and continuing review and approval