FDA 483 - Kent A. Swaine, MD - September 19, 2025

Novum Pharmaceutical Research Service in Las Vegas, NV, a Clinical Investigator (BA/BE Clinical), was cited for failing to conduct an investigation in accordance with the signed statement of investigator. The clinical investigator implemented unapproved protocol modifications without prior IRB approval and did not obtain revised informed consent from subjects. This resulted in 18 subjects participating under unapproved procedures.