Immunity Bio, Inc – FDA EIR, May 20, 2021

ImmunityBio, Inc., located in Culver City, CA, underwent an FDA inspection from May 17 to May 20, 2021. This initial inspection, conducted under the Sponsor, Contract Research Organizations and Monitors (CPGM) 7348.810 framework, focused on sponsor activities related to a specific investigational new drug (IND) protocol. Key areas reviewed included sponsor oversight, clinical investigator and monitor selection, data collection, monitoring activities, quality assurance, safety reporting, blinding, investigational product management, and electronic records compliant with 21 CFR Part 11.

During the inspection, no formal FDA Form 483 Inspectional Observations were issued, and no samples were collected. However, minor deficiencies were discussed with the company's management. These included an observed 1-hour 35-minute out-of-range temperature excursion for an investigational product shipment, initially lacking investigation documentation. ImmunityBio later provided an explanation regarding device acclimation and its effect. A second deficiency involved an employee holding two electronic record user roles—both blinded and unblinded—which could potentially affect the integrity of the randomization schedule, although management argued it would not significantly impact data. Additionally, the specific study under review was not registered on clinicaltrials.gov, but ImmunityBio confirmed they had decided not to proceed with it and had completed unblinding procedures and subject notifications. Despite the observations, no formal corrective actions were mandated.