FDA WARNING_LETTER - Gazda, Thomas M.D. - February 06, 2009

On January 20-February 6, 2009, the FDA inspected Dr. Thomas Gazda's conduct of a clinical investigation (b)(4) of the investigational drug (b)(4) for (b)(4). The inspection revealed non-adherence to statutory requirements and FDA regulations governing clinical investigations.

The FDA identified two primary violations: 1. **Failure to conduct the investigation according to the investigational plan [21 CFR 312.60]:** * Informed consent was not obtained by qualified personnel (M.D., Ph.D., or RN) or approved by (b)(4) for all subjects (1001-1008, 1010-1013). * Incorrect diagnostic instrument ((b)(4) instead of (b)(4)) was used for subjects 1008, 1010, 1011, 1012, and 1013. * (b)(4) was administered by a study coordinator, not the principal or sub-investigator, for subjects 1001-1007, and no documentation of rater-qualification training existed. * Daily subject/parent contact for monitoring was not documented for 10 of 11 subjects. * Subject 101