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

An FDA inspection conducted at Clinogent (Div of GVK Biosciences) in Ameerpet, Hyderabad, India, from March 9-13, 2015, identified several significant observations concerning their clinical and pharmacological unit. The inspection report, known as an FDA Form 483, highlighted a lack of adequate control and documentation for a specific clinical study. Key issues included discrepancies in archived electronic electrocardiogram (ECG) records, where multiple files existed for subjects but only one was integrated into the case report form, often without explanation for duplicates or exclusions. In some instances, ECGs were incorrectly attributed to different subjects or were found to be corrupted and unretrievable. Furthermore, the inspection revealed a critical absence of documentation confirming adverse event evaluations during the wash-out period between study periods. There was also a failure to document the assay system used for mandatory drug of abuse screenings, as stipulated in the study protocol. Lastly, the company did not maintain comprehensive correspondence files, specifically noting missing emails related to the shipment of investigational products. These observations indicate deviations from expected regulatory standards for clinical trials, falling under the authority of Section 704(b) of the Federal Food, Drug and Cosmetic Act. Clinogent is required to address these deficiencies to ensure the integrity and reliability of their clinical data and processes.