Which makes me wonder....will there come a day when everyone is using advanced control methods, PAT and online analytics to a point where FDA's inspections could be virtual, too? That day promises to be a long way off. (Especially given the atmosphere of "It's Mom, hide the beer" (Emil Ciurczak's description) at some plants when an FDA inspector arrives...)
Compliance can't be virtual, though. Now that companies receiving a 483 have a very limited time to respond, there's a need for a strategic approach and for putting responses in writing. Here, some guidance from FDA itself, from Anita Richards of the Office of Compliance and Biologics Quality, on how to respond to a 483.