FDA 483 - Rare Antibody Antigen Supply, Inc. - March 23, 2021

RAAS Nutritionals LLC, a sponsor of clinical investigations in Thousand Oaks, CA, was inspected by the FDA from March 15-23, 2021. The inspection revealed significant deficiencies in their conduct of clinical studies, including failure to submit Investigational New Drug (IND) applications, improper documentation of informed consent, and inadequate reconciliation of investigational drug supplies. These findings indicate serious non-compliance with regulations governing clinical research.