FDA 483 - Citrogein (Div of GVK Biosciences) - March 13, 2015

An FDA inspection of Citrogein (Div of GVK Biosciences), a Clinical Pharmacological Unit in Hyderabad, India, revealed significant issues with data integrity and record-keeping practices. Observations included discrepancies in electronic ECG records, lack of documentation for adverse event evaluations during study wash-out periods, and missing information regarding drug screening assay systems. Additionally, the firm failed to maintain complete correspondence files between the clinical site and the sponsor.