FDA 483 - GVK Biosciences Pvt. Ltd. - October 09, 2014

Clinogent (A Division of GVK Biosciences Pvt. Ltd.) in Ameerpet, Hyderabad, India, a Clinical & Analytical Contract Research Organization, was cited with three observations during an FDA inspection. The inspection revealed significant issues with standard operating procedures, including improper record archival and form accountability, as well as failures in maintaining accurate case histories and data. Additionally, the firm failed to obtain Ethics Committee approval for a study-specific informed consent form.