FDA EIR - MRIGlobal - August 26, 2022

An FDA comprehensive surveillance inspection was conducted at MRIGlobal's drug warehouse facility in North Kansas City, Missouri, on August 26, 2022. This inspection was performed under the FY22 work plan, adhering to Compliance Program 7356.002 for Drug Manufacturing Inspections, and was pre-announced due to COVID-19 protocols.MRIGlobal operates as a contract warehouse, private research facility, and pharmaceutical repository, primarily storing stability samples for testing. The inspection involved reviewing the firm's procedures, training records, change controls, and stability chamber qualification records. A thorough walk-through of the pharmaceutical stability facility and repository was also conducted.Significantly, no violations or issues were identified during this inspection. Consequently, no FDA Form 483, "Inspectional Observations," was issued, and no discussion items requiring attention were noted. The company's drug registration is current, and no regulatory actions have been taken against them previously.At the inspection's conclusion, management received a standard warning regarding their ongoing responsibility to comply with the Federal Food, Drug, and Cosmetic Act, noting potential consequences for non-compliance. No specific corrective actions or follow-up activities were mandated as a direct result of this inspection's findings. This classification indicates that the facility was found to be operating acceptably within the regulatory framework at the time of the inspection.