FDA WARNING_LETTER - Ponugoti, Nagarjuna R., M.D. - September 19, 2007

This FDA Warning Letter, Ref: 08-HFD-45-0202, was issued to Dr. Ponugoti of Allergy, Asthma & Immunology Associates of Terre Haute following an FDA inspection from September 10-19, 2007. The inspection reviewed the conduct of a clinical investigation (protocol [redacted]) for an investigational drug, part of the FDA's Bioresearch Monitoring Program.

The FDA concluded that Dr. Ponugoti failed to adhere to statutory requirements and FDA regulations for clinical investigations, citing five key violations:

1. **Failure to obtain and adequately document informed consent (21 CFR 50, 312.60):** For 30 of 34 subjects, informed consent was not obtained or documented by an IRB-approved, signed, and dated written form at the time of consent. IRB-approved forms were not completed until six months into the study. Assent was also not obtained from minor subjects. The "Authorization Form" used was deemed inadequate as it lacked required informed consent elements. 2. **Failure to promptly report unanticipated problems to the IRB (21 CFR 312.60, 312.66):** Two subject deaths and one hospitalization were not promptly reported to the IRB. Dr. Ponugoti's explanation of being unaware of this requirement or believing the sponsor would report was deemed unacceptable.