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FDA Warning Letter Explorer
FDA warning letter · Drugs

Richard J. Obiso, PhD dba Avila Herbals, LLC

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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)].

Passage 2

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].

Passage 3

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)].

Passage 4

You failed to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects [21 CFR 312.62(a)].

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 312.2(a)
  • 21 CFR 312.2
  • 21 CFR 312
  • 21 CFR 312.20(a)
  • 21 CFR 312.20
  • 21 CFR 312.66
  • 21 CFR 312.60
  • 21 CFR 312.62(a)
  • 21 CFR 50
  • 21 CFR 50.27(a)
  • 21 CFR 56
  • 21 CFR 56.109(c)