FDA 483 - Anuj Bhargava MD - December 17, 2020

Iowa Diabetes And Endocrinology Research in West Des Moines, IA, a clinical investigator, was cited for three observations during an FDA inspection. The observations primarily concern failures in conducting investigations according to plan, maintaining accurate records for device receipt, and ensuring accurate case histories due to illegible entries. These issues indicate deficiencies in data integrity and adherence to study protocols.