FDA 483 - Sudhirkumar Patel, MD - May 17, 2012

An FDA inspection of Sudhirkumar Patel, MD, a clinical investigator in Greenville, SC, revealed significant deficiencies in the conduct and documentation of clinical investigations. The firm failed to adhere to investigational plans by enrolling an ineligible subject, did not adequately maintain case histories, and could not provide required investigational records due to issues with a Contract Research Organization.