Antonio E. Blanco, M.D./Vista Health Research, LLC – FDA Warning Letter, Jan 30, 2023

The FDA issued a Warning Letter to Dr. Blanco following an inspection from January 11-30, 2023, under the Bioresearch Monitoring Program, which revealed objectionable conditions in the conduct of clinical investigations, specifically Protocol (b)(4). The inspection found that Dr. Blanco failed to ensure the investigation was conducted according to the investigational plan, violating 21 CFR 312.60.

Key violations include: 1. **Failure to meet inclusion criteria:** Eight subjects were randomized without proper documentation of a surgical diagnosis of (b)(4) within 10 years prior to study entry. The provided retroactive documentation for three subjects was inadequate as the surgeries occurred more than 10 years prior. 2. **Inadequate e-Diary documentation:** One subject was randomized without the required e-Diary entries for (b)(4) to support eligibility. 3. **Missed safety imaging procedures:** Protocol-required (b)(4) and (b)(4) safety imaging procedures were not performed for three subjects at specified time points (e.g., Month 6, Month 12, Month 18).

Dr. Blanco's February 17, 2023, response to the Form FDA 483 was deemed inadequate. While corrective actions like reviewing and revising procedures, conducting quality reviews, and implementing quarterly record reviews were proposed, the response lacked sufficient detail on implementation