On March 18, 2020, the United States Food and Drug Administration (FDA) announced that it was suspending routine surveillance audits in the United States. This follows the decision made by the Agency to stop conducting facility inspections in China in February and other overseas locations earlier in March 2020.
FDA Commissioner Stephen Hahn noted that “for the health and well-being of our staff and those who conduct inspections for the agency under contract at the state level, and because of industry concerns about visitors, we have temporarily postponed all domestic routine surveillance facility inspections.”
These facility inspections are typically conducted by the FDA every few years “based on a risk analysis.” He did note, however, “all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical.”
While in-person visits are suspended, the FDA is looking at different ways for its investigators to perform inspection work, including “evaluating records.” When the FDA announced the Chinese investigations were paused, the FDA referred to other “tools,” including import alerts, increased import sampling and screening, record requests, and company compliance histories with regulators in other countries.
Commissioner Hahn reiterated the FDA’s commitment to “using all available tools to oversee the safety and quality of FDA-regulated products for American patients and consumers” and that the Agency has “full confidence in the safety and quality of the products we all use every day, and that the FDA will continue to leverage all available authorities to continue to ensure the integrity of the products we regulate.”
He also noted that it isn’t the inspections that “cause quality to happen,” but that “safety and quality need to be owned by the industry, and firms have the primary responsibility to reliably produce quality products.” Hahn gave the example of medical product and food industries regulate by the FDA, which are subject to certain reporting requirements about their facilities and also must adhere to Current Good Manufacturing Practice (cGMP) requirements pertaining to, for example, operating procedures, manufacturing, sanitation, and processing controls, as well as preventive controls to reduce or eliminate food safety hazards.
Commissioner Hahn gave domestic companies credit, noting “last fiscal year, the overall domestic violation rate was only about 5%.”
Commissioner Hahn has not indicated when United States inspections will resume, and audits of facilities in China will not resume until May 2020 at the earliest.