FDA to Resume Routine Domestic Facilities Inspections
USAgNet - 07/14/2020
The U.S. Food and Drug Administration (FDA) announced that the agency will resume routine inspections of domestic facilities during the week of July 20. FDA had paused routine inspectional activities due to the COVID-19 pandemic in March.
FDA will use the White House Guidelines for Opening Up America Again, as well as the Centers for Disease Control and Prevention (CDC) guidance for protecting workplace exposures when scheduling and conducting its field activities. In addition, national,
state and county-level data will be evaluated when making decisions about where and when to conduct inspections.
During a conversation with Dr. Timothy Schell, Director of the Center for Veterinary Medicine's Office of Surveillance and Compliance, the NGFA was told that FDA at this time will continue its practice of preannouncing inspectional activities so that facilities
can be appropriately prepared for the investigator's visit. In addition, Schell said that inspectional activity will resume in a deliberate manner, and that the agency does not intend to try to "catch-up" on the number of inspections for the time period during which
inspections were suspended. As such, FDA inspections will continue to be scheduled by the agency based on a risk-based approach that considers a variety of factors associated with the regulated facility.