FDA 483 - David R. Hassman, DO - July 18, 2014

An FDA inspection of David R. Hassman, D. O., Principal Investigator, in Berlin, NJ, identified a significant deviation from the investigational plan. The firm failed to conduct the study in accordance with the protocol, specifically regarding the timing of audiology assessments and various study visits. This non-compliance impacts the integrity of the clinical trial data for Protocols HYD3002 and HYD3003.