FDA WARNING_LETTER - Namita A. Goyal, M.D. - June 23, 2023

The FDA issued a Warning Letter to Dr. Goyal following a Bioresearch Monitoring (BIMO) inspection from June 12-23, 2023, at a clinical study site, reviewing the conduct of a clinical investigation. The inspection revealed significant violations of regulations governing clinical studies involving investigational products (21 CFR 312 and 50), leading to a Form FDA 483 and subsequent Warning Letter despite the firm's responses. Key violations include the failure to conduct the investigation according to the signed investigator statement, investigational plan, and applicable regulations (21 CFR § 312.60), encompassing enrolling ineligible subjects, administering investigational product prior to release, and allowing unauthorized personnel to perform study tasks. The firm also failed to obtain legally effective informed consent (21 CFR § 50.20), with instances of non-subjects signing consent forms, un-impartial witnesses, and genetic testing performed without documented consent. Furthermore, there was a failure to assure IRB compliance and obtain approval for changes in research activity (21 CFR § 312.66), specifically regarding IRB members with conflicting interests and the use of an unapproved screening questionnaire. Significant deficiencies were also noted in preparing and maintaining adequate and accurate case histories (21 CFR § 312.62(b)), including unrecorded adverse events, missing bone marrow aspiration records, unreviewed hospitalization records, unrecorded concomitant medications, and unjustified duplicate ECG assessments. Additional concerns highlighted compromised data reliability due to an uncalibrated spirometer affecting 50 SVCs and inaccurate, non-contemporaneous protocol training logs. The FDA expressed significant concerns about the validity and integrity of all data collected at the site. Dr. Goyal is required to respond within 15 working days with specific corrective and preventative actions, including documentation, to address these systemic compliance issues and prevent recurrence, or face potential regulatory action.