Dear Colleagues --
Yesterday we received this important announcement from the FDA. Here are my takeaways:
"...we have temporarily postponed all domestic routine surveillance facility inspections. These are facility inspections the FDA traditionally conducts every few years based on 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."
"...evaluating records in lieu of conducting an onsite inspection on an interim basis when travel is not permissible, when appropriate."
Stay safe and well. Please let us know if you have any questions. Your UNPA staff are working from our home offices and are here to help.