FDA 483 - Luis F. Soruco, MD - August 12, 2026

An FDA inspection of Luis F. Socuro, M.D. in Arlington Heights, IL, revealed significant non-compliance in the conduct of clinical investigations. The firm failed to adhere to the signed investigator statement, report unanticipated problems to the IRB, and maintain adequate and accurate case histories. These deficiencies indicate serious issues with protocol adherence, human subject protection, and data integrity.