FDA 483 - Nicola P. Klein, M.D. - January 03, 2022

Nicola P. Klein, M.D., a clinical investigator in Oakland, CA, was cited for significant deficiencies in conducting and supervising clinical investigations. The inspection revealed failures in ensuring proper subject assessments, adverse event reporting, and maintaining complete case histories, including a missing informed consent form. These issues indicate a lack of adherence to investigational plans and regulatory requirements for clinical trials.