FDA EIR - Nicola P. Klein, M.D. - January 03, 2022

An FDA inspection of Nicola P. Klein, M.D., located in Oakland, CA, was conducted from December 13, 2021, to January 3, 2022, under the FDA Bioresearch Monitoring program (compliance program 7348.811) for clinical investigators. The inspection focused on Dr. Klein's conduct as Principal Investigator for two study protocols involving an investigational product. The inspection resulted in the issuance of a FORM FDA 483, detailing two main observations. The first observation highlighted that investigations were not conducted according to the signed statement of investigator and investigational plan, specifically citing a lack of direct personal conduct or supervision. This included authorizing investigational product administration via a "standing order" without prior physician review of physical exams, medical histories, or concomitant medications. Furthermore, inclusion/exclusion criteria were not timely reviewed by physician investigators before subject enrollment or product administration. Physician sub-investigators failed to conduct initial assessments of adverse events, including their relationship to the investigational product, before reporting to the sponsor. Several instances of concomitant medications and subject diagnoses were also not reported to the sponsor, and physical exam measurements were omitted. The second observation noted a failure to maintain adequate case histories regarding informed consent. This included not maintaining a subject's informed consent form and incomplete consent forms lacking information on alternate treatments for study-related injuries or contact details for further information. These observations, referenced against 21 CFR 312.60, require corrective actions from Dr. Klein to ensure compliance with regulatory requirements for clinical investigations.