FDA 483 - GVK Biosciences Pvt. Ltd.

Clinogent, a Clinical & Analytical Contract Research Organization in Hyderabad, India, was cited for significant deficiencies during an FDA inspection. The firm failed to establish and follow standard operating procedures for record archival and form accountability, maintain accurate case histories and data, and ensure proper Ethics Committee approval for informed consent forms. These issues indicate a lack of control over critical aspects of clinical and analytical study conduct.