As FDA Resumes Domestic Inspections While Keeping Foreign Inspections on Hold, Questions Remain About the Agency's Ability to Keep Tabs on the Global Supply Chain

Skadden attorneys Jennifer Bragg, Maya Florence, William McConagha and Pamela Amaechi look at the FDA's July 2020 announcement that it plans to resume domestic facility inspections after suspending most foreign and domestic inspections because of the COVID-19 pandemic. FDA-regulated domestic companies should prepare for the resumption of on-site inspections, while entities abroad should continue to follow good manufacturing practices in anticipation of an eventual resumption of foreign facility inspections.