A spokesperson from the U.S. Food and Drug Administration (FDA) reported that the FDA has no intentions of resuming onsite GMP foreign inspections for non-“mission critical” operations during the COVID-19 pandemic. Further, the agency intends on continuing to use mutual recognition agreements (MRAs) for third countries covered under the European Union regulators in place of onsite inspections. Regarding remote site inspections, Lori Graham, Director of the Division of Internal Policies and Programs of the CDER’s Office of Pharmaceutical Quality, stated, “Records requests and remote inspections do not meet the statutory requirements for a boots-on-the-ground inspection. Without a statutory change, there will be no plans to change that.”
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