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

An FDA inspection of Clinogent (A Division of GVK Biosciences Pvt. Ltd.) in Hyderabad, India, was conducted from September 29 to October 9, 2014. The inspection, which also included representatives from the European Medicines Agency, identified significant deficiencies in the company's adherence to regulatory frameworks concerning study conduct and record integrity.

Key violations included a failure to maintain accurate study records, such as discrepancies between centrifugation and freezing times for samples. A major concern was the lack of control and reconciliation of quality assurance (QA) issued study records, with unarchived forms and raw data from previous years found unsecured. Furthermore, the Ethics Committee had not reviewed or approved study-specific informed consent forms that included handwritten additional screening procedures, leading to inconsistent information provided to volunteers. Other issues noted were unsecured access to critical laboratory and archival areas, and the absence of a Standard Operating Procedure for the use of "extra" study subjects.

These observations highlight the need for Clinogent to implement robust corrective and preventive actions to ensure compliance with good clinical and laboratory practices, enhance data integrity, and strengthen their quality management system, particularly regarding document control and informed consent processes, in accordance with applicable regulatory guidelines.