FDA 483 - Luis F. Soruco, MD - August 23, 2019

An FDA inspection conducted at Luis F. Socuro, M.D., a clinical investigator in Arlington Heights, IL, from August 2 to August 23, 2019, identified significant deficiencies in the conduct of clinical investigations. The observations, issued under the Federal Food, Drug, and Cosmetic Act, primarily highlighted a failure to adhere to the signed statement of investigator and study protocols. Specific issues included multiple instances of incorrect investigational drug dispensing, omitted pregnancy tests, unapproved contraception methods, and improper collection and analysis of study samples. Furthermore, the firm failed to adequately document and report adverse events to the sponsor and the Institutional Review Board (IRB) in a timely manner, including serious adverse events and investigational product dispensing errors, which are critical for human subject protection. Finally, the inspection revealed a failure to maintain comprehensive and accurate case histories, evidenced by missing IRB-approved documents like Informed Consent Forms and a lack of proper documentation for the preparation, storage, and shipment of study samples. The firm is expected to address these observations by implementing appropriate corrective actions to ensure compliance with regulatory standards for clinical research.