FDA EIR - LA Universal Research Center Inc. - May 24, 2019

An FDA surveillance inspection of LA Universal Research Center, Inc. was conducted from May 20-24, 2019, in Los Angeles, CA. The inspection, performed under Compliance Program Guidance Manual 7348.003 Bioresearch Monitoring, In-Vivo Bioavailability/Bioequivalence, aimed to verify clinical data supporting a generic drug submission. Dr. Reynaldo L. Makabali served as the Principal Investigator. The inspection scope included protocol adherence, informed consent, data integrity, investigational product accountability, and IRB approvals. Notably, the inspection concluded without the issuance of an FDA-483 Inspectional Observations List, indicating no objectionable conditions requiring formal corrective action. Minor issues identified and addressed during the inspection included protocol deviations such as missed lab tests for one subject and a minor randomization number assignment discrepancy for two subjects. These deviations were reported to the sponsor and Institutional Review Board, and site staff received retraining. Additionally, Certificates of Analysis for study drugs, initially not available at the site, were provided by the sponsor during the inspection. Overall, study records were found to be neat and organized, reflecting a compliant operation.