FDA 483 - Zubin Punthakee, MD - July 22, 2016

The FDA inspected Zubin Punthakee, MD, a clinical research site, and found significant deviations from good clinical practice. The firm failed to conduct an investigation in accordance with the investigational plan, specifically regarding dose adjustments for subjects with declining renal function. Additionally, the firm did not maintain accurate case histories, leading to misrepresentation of subject medical conditions.