On March 18, 2020, the U.S. Food and Drug Administration (FDA) announced that it has temporarily postponed all domestic routine surveillance facility inspections, which include facility inspections that the FDA traditionally conducts every few years based on a risk analysis. FDA noted that all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical.  FDA made this announcement in order to protect the health and well-being of its staff and those who conduct inspections for the agency under contract at the state level.

In order to help slow the spread of the virus, help flatten the curve of the COVID-19 pandemic, and ensure that its workforce remains healthy to carry out the FDA’s critical public health mission, FDA directed all eligible FDA employees to begin teleworking.  However, FDA noted that this does not apply to those carrying out non-portable activities, such as certain lab activities or the monitoring of imported products.  In its announcement, FDA mentioned that it is evaluating additional ways to conduct its inspection work that would not jeopardize public safety.  For example, FDA may evaluate records instead of conducting an onsite inspection on an interim basis when travel is not permissible.

A few weeks ago, FDA also announced that it is postponing most foreign facility inspections through April, and that only inspections that are deemed mission-critical outside the U.S. will be considered on a case-by-case basis.  We will continue to monitor any developments.