The House, the Senate, and the President of the United States failed to reach an agreement on a short-term spending bill to extend funding for seven federal departments including the Department of Health and Human Services that funds the FDA.
As a result, the FDA has furloughed 41% of its staff—some 7,000+ employees in total.
While some of the mission-critical functions of the FDA (core emergency response functions, high-risk recall activities, and some of the agency’s user-fee funded work) will still operate during the shutdown, some of FDA’s “routine regulatory and compliance” work, inspections, and research activities have halted. In addition, all FOIA (Freedom of Information Act) requests are no longer being processed.
“Mission critical surveillance for significant safety concerns with medical devices and other medical products will continue,” FDA said. “FDA would be unable to support some routine regulatory and compliance activities. This includes some medical product, animal drug, and most food-related activities. FDA will also pause routine establishment inspections, cosmetics and nutrition work, and many ongoing research activities.”
Impact on FDAzilla Subscribers and Customers
If you are a FDAzilla subscriber or store customer and have requested a copy of a 483 or other FDA inspection document not currently in our database, we will not be able to retrieve these for you until after the government reopens.
In addition, we expect response times for future requests will be increased until the backlog created by the shutdown has disappeared.
Fortunately, we have the largest library of FDA inspection documents available so you’ll be able to continue to get most of the information you need during this difficult time! If you are not able to find something in particular and need some assistance, please do not hesitate to contact us. It might take a bit longer than usual, but we will get what you need to you as soon as possible.
Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483s, InspectorProfiles, Enforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at firstname.lastname@example.org.
About the Author
Michael de la Torre is the CEO of FDAzilla.