FDA EIR - L.A. UNIVERSAL RESEARCH CENTER Inc. - April 03, 2019

L.A. Universal Research Center, Inc. underwent an FDA pre-market GDUFA inspection for Bioresearch Monitoring of In Vivo Bioavailability/Bioequivalence Studies from March 27 to April 3, 2019. This was the clinical site's initial FDA inspection. The inspection covered various aspects, including review of study records, informed consent processes, and test article accountability for a study involving twenty-four subjects. While no official FDA Form 483 (Inspectional Observations) was issued, two significant discussion items were raised with management. The first concern involved the failure to report four non-serious adverse events, documented by subjects in their diaries, to the study sponsor by not entering them into the electronic case report forms. These included various temporary symptoms. The Principal Investigator, Dr. Torkan, acknowledged that all symptoms, even temporary ones, should be reported in the future. The second issue was that the informed consent form provided to subjects did not adequately list all potential risks, specifically omitting the risk of hypopigmentation, which was detailed in the product's Full Prescribing Information. Dr. Torkan committed to ensuring that all risks from product labeling and brochures are comprehensively included in future informed consent forms. The inspection emphasized the importance of thorough adverse event reporting and comprehensive informed consent to comply with regulatory requirements for clinical studies.