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

An FDA inspection of Clinogent (A Division of GVK Biosciences Pvt. Ltd.) in Ameerpet, India, was conducted from March 10-13, 2015, focusing on a specific bioequivalence study. The inspection revealed several significant issues concerning data integrity and documentation practices. Key violations included the failure to consistently document all electrocardiogram (ECG) files within subject Case Report Forms (CRFs), with multiple ECG recordings for some subjects lacking clear justification for their inclusion or exclusion. Furthermore, there was no documented evidence that subjects were evaluated for adverse events during the wash-out period between study periods, a critical oversight for patient safety monitoring. The facility also failed to maintain complete records for urine drug screening tests, specifically lacking details on the assay system, manufacturer, lot numbers, and expiration dates. Lastly, essential communications between Clinogent and the study sponsor, such as product shipment requests, were not adequately retained in the correspondence files. These observations highlight deficiencies in adhering to regulatory standards for clinical trial conduct and record-keeping. In response, Clinogent committed to providing a formal reply to the FDA's findings within 15 days. Management was also advised to implement rigorous audits of electronic ECG files to ensure comprehensive reporting and appropriate handling. Notably, the firm had already initiated the process of permanently closing its Hyderabad facility, effective June 2015, due to unfavorable business conditions, though regulatory archives were promised to remain accessible.