Zaiac, Martin N. – FDA Warning Letter, Jul 14, 2010

This FDA Warning Letter, dated March 21, 2011, addresses Dr. Martin Zaiac of Greater Miami Skin and Laser Center following an FDA inspection conducted from April 22 to July 14, 2010. The inspection reviewed Dr. Zaiac's conduct of a clinical investigation (Protocol (b)(4), Version 4.0) of the investigational drug (b)(4) for (b)(4).

The FDA concluded that Dr. Zaiac failed to adhere to statutory requirements and FDA regulations governing clinical investigations and human subject protection. Key violations include:

1. **Failure to Personally Conduct or Supervise the Clinical Investigation [21 CFR 312.60]:** Dr. Zaiac inadequately supervised delegated tasks, leading to issues like enrollment of ineligible subjects and failure to follow safety monitoring procedures for abnormal laboratory values and QTcF intervals. 2. **Failure to Conduct Studies According to Investigational Plan and Protect Subject Safety/Welfare [21 CFR 312.60]:** * Failure to follow protocol for elevated QTcF values in subjects 0270309, 0270393, and 02700419, including not admitting subjects to telemetry/emergency units, performing repeat ECGs, electrolyte monitoring, or cardiologist consultations. * Enrolling and maintaining ineligible