FDA 483 - Parag Kalyani, MBBS, MD, Clinical Investigator - July 01, 2024

During an FDA inspection from June 24 to July 1, 2024, at Parag Kalyani, MBBS, MD, Clinical Investigator in Pune, India, significant deviations from Good Clinical Practices were observed during a bioequivalence/bioavailability clinical study. The core issues highlight systemic failures in data integrity and documentation control. Findings included inadequate and inconsistent case histories, with discrepancies between subject diaries and photocopies, some showing signs of alteration or overwriting. Crucial study documentation, such as informed consent forms and follow-up records, was not consistently stored in designated subject files but found in an unsecured cabinet. Evidence indicated routine removal and rewriting of source documents, including Case Report Forms and prescription pages, to introduce unverified changes. Numerous data discrepancies were noted, such as conflicting lesion counts and inconsistent investigator assessments. Duplicate or partially completed records for prescriptions, diaries, and urine pregnancy tests often contained inconsistent information or lacked proper identification. Furthermore, multiple temperature logs for investigational product storage showed conflicting readings and recording times. The inspection also revealed inadequate assessment and reporting of adverse events, with subjects' reported reactions in diaries not always being fully documented or assessed per protocol. These observations necessitate comprehensive corrective actions to ensure compliance with regulatory standards.