FDA 483 - GVK Biosciences Pvt. Ltd. - October 09, 2014
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 5263bf56-f768-4bd1-8172-22de6d9e4405