The FDA announced today that it has temporarily suspended all routine domestic inspections of regulated facilities during the coronavirus outbreak.
The move is designed to protect agency employees as well as those who conduct inspections for the agency under contract at the state level and from a desire by regulated facilities to restrict visitors, according to FDA commissioner Dr. Stephen Hahn.
“Protecting the health and safety of our staff and their families is of paramount concern to the U.S. Food and Drug Administration,” Hahn said in a statement. “As a nation we must do everything we can to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic. Now more than ever, the American people are depending on us. We must ensure our workforce remains healthy to carry out the FDA’s critical public health mission to keep Americans safe.”
The suspension covers inspections of all FDA-regulated products, including medical devices, drugs, biological products, food, animal feed and tobacco. These are facility inspections the FDA traditionally conducts every few years based on a risk analysis.
All domestic for-cause inspection assignments will be evaluated and will proceed if the FDA deems them critical as the outbreak continues to unfold, the agency said. No date for resuming regular inspections was provided.
The FDA based this decision on a number of factors, including State Department prohibitions on travel by federal employees, Centers for Disease Control and Prevention travel recommendations, other countries’ restrictions on foreign visitors and guidance from the Office of Personnel Management.
“Another critical factor in taking this action is the confidence we have in our ability to maintain oversight over international manufacturers and imported products using alternative tools and methods,” Hahn said.
Hahn said the agency also directed all eligible FDA employees to begin teleworking. That order does not apply to those who carry out certain lab activities or monitor imported products,
The decision to postpone domestic inspections follows a similar one the FDA made about foreign inspections March 10, although that pause is slated to end April 30. At the time, the agency said it would consider performing foreign inspections it deems mission-critical on a case-by-case basis.
Hahn said the FDA will continue to respond to domestic natural disasters, outbreaks and other public health emergencies involving products it regulates.
“I want to assure the American public that we have 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,” Hahn said. “Importantly, during this interim period we’re evaluating additional ways to conduct our inspectional work that would not jeopardize public safety and protecting both the firms and the FDA staff. This can include, among other things, evaluating records in lieu of conducting an onsite inspection on an interim basis when travel is not permissible, when appropriate.”
“Inspections are not what causes quality to happen,” Hahn added. “Safety and quality need to be owned by the industry and firms have the primary responsibility to reliably produce quality products.”
Medical product and food industries are subject to reporting requirements about their facilities and also must adhere to Current Good Manufacturing Practice (cGMP) requirements that pertain to things like operating procedures, manufacturing, sanitation, and processing controls, Hahn added.
“From our experience across the agency, we also believe FDA-regulated firms understand and appreciate their shared responsibility to ensure the integrity of the supply chain and we will continue to communicate with them during this time to underscore this partnership,” he said. “In fact, in last fiscal year, the overall domestic violation rate was only about 5%. The FDA remains committed to using all available tools to oversee the safety and quality of FDA-regulated products for American patients and consumers. As this remains a dynamic situation, we will continue to assess and calibrate our approach as needed and we stand ready to resume any postponed inspections as soon as feasible.”
