GVK Biosciences Pvt. Ltd. – FDA EIR, Mar 30, 2011

An FDA inspection of GVK Biosciences Pvt. Ltd. in Ameerpet (Hyderabad), India, was conducted from March 22 to March 30, 2011. This "for cause" inspection, under C.P. 7348.001, specifically investigated a subject death and a serious adverse event during a bioequivalence study (ANDA 91-484, Study 153-08). The regulatory framework for clinical research and bioequivalence guided the audit of clinical and analytical facilities, subject records, and procedures. The inspection identified several critical violations documented on an FD-483. GVK Biosciences failed to adequately justify and document the enrollment of subjects into studies 145-08, 153-08, 254-09, and 255-09 who exhibited elevated QT/QTc intervals (>450ms) in ECG readings, conflicting with FDA's E14 guidance on cardiac repolarization. Furthermore, the company lacked documentation to verify that lighting conditions in drug dispensing, dosing, and sample processing areas met protocol requirements for minimal ultraviolet light exposure. Deficiencies also included a failure to ensure special handling for light-sensitive samples during processing and inadequate maintenance of study-related correspondence files. Management verbally committed to implementing immediate corrective actions to rectify these significant observations, which are crucial for subject safety and data integrity.