FDA 483 - ZenRise Clinical Research Pvt., Ltd - January 20, 2023

ZenRise Clinical Research Pvt., Ltd. in Hyderabad, India, was inspected from January 16-20, 2023, and cited for significant deficiencies in conducting clinical bioequivalence studies. The observations include failures in reporting adverse events, maintaining complete and accurate records, and proper investigational product accountability. These issues indicate a lack of adherence to Good Clinical Practices.