FDA WARNING_LETTER - Fandino, Ana J. - May 22, 2013

The FDA issued a Warning Letter to Dr. Ana J. Fandino following an inspection from May 6-22, 2013, concerning her conduct in clinical investigations of investigational drugs (b)(4) and (b)(4). The inspection, part of the Bioresearch Monitoring Program, identified significant violations of FDA regulations and statutory requirements.

Key violations include: 1. **Failure to Personally Conduct or Supervise Investigations (21 CFR 312.60):** Dr. Fandino inadequately supervised delegated study tasks, leading to ineligible subject enrollment in Protocols (b)(4) and (b)(4), and insufficient precautions against theft/diversion of investigational drug (b)(4), a Schedule II controlled substance. Her June 3, 2013, response, citing lack of experience and unqualified staff, was deemed inadequate due to insufficient SOPs and lack of detail on staff training. 2. **Failure to Conduct Investigation According to Plan (21 CFR 312.60):** Dr. Fandino failed to ensure subjects met eligibility criteria. For Protocol (b)(4), four of ten enrolled subjects (016, 018, 020, 022) were diagnosed with (b)(4) more than five years prior to consent, violating the five-year requirement. For Protocol (b)(4), subjects 03