The ConOps created 90-day facility classification decisional letters to meet the GDUFA II commitment. FDA’s inspection classification is sent in a letter to the facility within 90 days from the end of an inspection. There are separate letters used depending on the facility classifications:
no action indicated (NAI)
voluntary action indicated (VAI)
official action indicated (OAI)
The 90-day decisional letters explain what the classification means as well as how it may impact a company’s application approval.