The FDA has issued a statement on its response to the COVID-19 pandemic. In an effort to protect the health and safety of its own workforce, the FDA will be asking its employees to telecommute when possible, and it is scaling back certain operations, such as domestic inspections.

Earlier this month, we announced that we are postponing most foreign facility inspections through April and that inspections outside the U.S. deemed mission-critical will be considered on a case-by-case basis as this outbreak continues to unfold.

Today, we’re announcing 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 are facility inspections the FDA traditionally conducts every few years based on a risk analysis. Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical. We will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products.

In fact, inspections are just one part of a robust and multi-pronged approach to overseeing the safety and quality of FDA-regulated products, however inspections are not what cause quality to happen. Safety and quality need to be owned by the industry and firms have the primary responsibility to reliably produce quality products. For example, the medical product and food industries we regulate 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.

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. In fact, in last fiscal year, the overall domestic violation rate was only about 5%.

Read the entire statement from the FDA.