After a four-month hiatus in which it suspended inspection
activities because of the coronavirus pandemic, the United States
Food and Drug Administration (FDA) announced on July 10, 2020, that
it will resume on-site inspections of regulated facilities. The FDA
had previously announced on March 10 that routine domestic
inspections would be put on hold to protect the health of its
inspectors.
Advance notice of the inspections will be provided for now. The
only exception will be for retail tobacco sites because those
inspections are typically undercover operations where the retailer
is unaware that an inspection is taking place.
Inspections will begin the week of July 20. The FDA will resume
inspections in accordance with the White House Guidelines for
Opening Up America Again, which means that inspections will resume
only in geographic areas where COVID-19 infection rates and
hospitalizations are declining. The FDA has developed a rating
system to determine when and
