FDA 483 - Joseph A. Zadra, MD - May 07, 2026

During an FDA inspection conducted from May 3-7, 2021, the clinical investigator firm Joseph A. Zadra, MD, received a Form 483 detailing significant observations related to the conduct of a clinical trial. The primary finding indicated that the investigation was not carried out in accordance with the signed investigator statement and the approved investigational plan.

Specifically, the inspection revealed multiple instances of non-compliance. Four out of five enrolled subjects failed to meet the Research Ethics Board-approved inclusion and exclusion criteria, jeopardizing data integrity and patient safety. Examples included enrolling a subject with a history of malignancy requiring concurrent cancer therapy, another with abnormal kidney function, a third who had not received the required prior treatment, and a fourth with pre-existing thrombocytopenia and unreadable screening lab results.

Furthermore, dosing procedures deviated from the protocol. One subject was dosed with investigational product even after the Medical Monitor instructed a cessation of treatment. Additionally, two subjects received investigational product doses within a 48-hour window, violating the protocol's minimum dosing interval. Finally, required clinical laboratory tests were not performed for several subjects at various specified visits, indicating a failure in data collection as per the protocol.

These observations highlight deficiencies in adhering to clinical trial protocols, which are critical for ensuring patient safety and the reliability of study data under FDA regulations. Joseph A. Zadra, MD, is required to address these findings and implement corrective actions to ensure future compliance.