FDA 483 - Receptor Holdings Inc. DBA Receptor Life Sciences, Inc - July 07, 2021

Receptor Holdings Inc. DBA Receptor Life Sciences, Inc in Seattle, WA, was cited for a significant regulatory violation during an FDA inspection. The firm conducted a clinical investigation involving an investigational new drug with 35 subjects between August 2019 and March 2020 without first submitting an Investigational New Drug (IND) application to the FDA. This indicates a serious failure to comply with regulatory requirements for clinical trials.