David Pham, M.D. – FDA EIR, Jun 18, 2025

FDA conducted the initial, pre-announced Bioresearch Monitoring (BIMO) inspection of clinical investigator David N. Pham, MD (Allianz Research Institute Co, Aurora, CO) between May 13 and June 18, 2025 (12 days on site) under compliance program 7348.811 and a CDER assignment, reviewing several sponsor clinical studies at a site that runs respiratory trials (asthma, COPD, RSV). Significant staff turnover, protocol training by 'self-review', an unlisted local laboratory with incorrect reference ranges, and a mid-study change of Principal Investigator after a sponsor licensure concern were noted. A Form FDA 483 was issued on June 18, 2025 with five observations: the investigation was not conducted per the signed statement of investigator (ineligible subjects enrolled, investigational product overdoses and dosing errors, missed protocol assessments; 21 CFR 312.60); informed consent was not obtained with the current IRB-approved consent forms and subjects were not re-consented; case histories were inadequate and inaccurate (missing consent and source records, wrong lab reference ranges in the EDC, unreported adverse events; 21 CFR 312.62(b)); the IRB was not told of licensure and disciplinary actions for research staff (21 CFR 312.66); and drug disposition records were inadequate, with shipments of investigational product lost (21 CFR 312.62(a)). The 483 was amended twice (June 24 and July 2025). Dr. Pham responded on July 8, 2025; no samples were collected and no voluntary corrections were made.