FDA EIR - Richard De La Garza, II, Ph.D - January 23, 2012

The FDA conducted a High Priority Clinical Investigator Data Validation Inspection at Richard De La Garza, II, Ph.D., located at the Michael E. DeBakey VA Medical Center in Houston, Texas. The inspection spanned from November 8, 2011, to January 23, 2012, focusing on compliance with Good Clinical Practice (GCP) standards for three Investigational New Drug (IND) applications. Dr. De La Garza, serving as both Principal Investigator and Sponsor-Investigator, was primarily responsible for these studies.

Key violations identified during the inspection included non-compliance with the investigational plan, such as failure to adhere to protocol stopping rules and dosing guidelines, inadequate involvement in adverse event assessments, and improper management of investigational drug disposition records. Additionally, the randomization scheme was not followed for two subjects. These issues resulted in the closure of one study by the sponsor due to GCP deficiencies.

The inspection was conducted under the regulatory framework of CP7348.811, focusing on Clinical Investigators/Sponsor-Investigators. An FDA-483 form was issued, detailing the inspectional observations, and Dr. De La Garza committed to making necessary corrections. The FDA expects the investigator to address these deficiencies to ensure compliance with regulatory standards and safeguard the integrity of clinical research. No refusals were encountered during the inspection process.