FDA EIR - Bernadette D'Souza, MD - March 18, 2015

An FDA for-cause inspection of Bernadette D'Souza, MD, operating as Midwest Clinical Research, was conducted from March 3 to March 18, 2015. This bioresearch monitoring inspection, guided by regulatory framework 21 CFR 312.60, focused on the clinical investigator's adherence to study protocols.

The main violation, which led to the issuance of an FDA Form 483, was the failure to conduct an investigation in accordance with the investigational plan. Specifically, a subject in a Phase 3 study was enrolled despite not meeting the required washout period for a restricted medication, thus violating established exclusion criteria.

Two additional significant issues were discussed: firstly, another subject in a separate Phase 4 study was enrolled without fulfilling the inclusion criterion for stable treatment over a minimum duration. This was self-identified by Dr. D'Souza as a protocol deviation during the inspection. Secondly, a concerning documentation practice was identified where vital sign records displayed consistent handwriting across multiple entries but bore different staff signatures, suggesting improper record-keeping by the individual performing the task. Dr. D'Souza committed to providing a written response to the FDA within 15 business days addressing these observations and concerns.