Richard J. Obiso, PhD dba Avila Herbals, LLC — FDA Warning Letter Findings

You failed to assure that an Institutional Review Board (IRB) that complies with the requirements set forth in 21 CFR part 56 was responsible for the initial and continuing review and approval of the proposed clinical study [21 CFR 312.66]. As a clinical investigator, you are required to assure that an IRB that complies with the requirements set forth in 21 CFR part 56 is responsible for the initial and continuing review and approval of a proposed clinical investigation. You…

Failure to submit an Investigational New Drug application (IND) for the conduct of a clinical investigation with an investigational new drug that is subject to 21 CFR 312.2(a) [21 CFR 312.20(a), 312.20(b), and 312.40(a)]. Section 201(g) of the FD&C Act defines the term drug in part as “articles recognized in the . . . official (b)(4) . . . ,” and as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” [21…

You failed to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects [21 CFR 312.62(a)]. As a clinical investigator, you are required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects. You failed to comply with this requirement. Specifically, you failed to maintain drug disposition records for any of the (b)(4) subjects enrolled at your site who received (b)(4) . In…

You failed to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR 50.27(a)]. As a clinical investigator, you are required to obtain informed consent in accordance with 21 CFR part 50. Except as provided in 21 CFR 56.109(c), informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent…