FDA 483 - Milind Javle, MD - December 21, 2020

Milind Javle, MD, a clinical investigator in Houston, TX, was cited for significant deficiencies during an FDA inspection. Observations included lapses in IRB continuing review, failure to adhere to the investigational plan for subject procedures, and critical failures in obtaining informed consent and timely reporting of serious adverse events to the sponsor. These issues indicate a lack of control over key aspects of clinical trial conduct and subject protection.