FDA 483 - GVK Biosciences Pvt. Ltd. - March 13, 2015

An FDA inspection of Clinogent (Div of GVK Biosciences) in Hyderabad, India, a Clinical Pharmacological Unit, revealed significant deficiencies in record-keeping and study documentation. Observations included issues with electronic ECG records, lack of adverse event evaluations, missing drug screening assay information, and inadequate maintenance of correspondence files. These findings highlight concerns regarding data integrity and the proper conduct of clinical studies.