About the Office of Regulatory Affairs
The U.S. Food and Drug Administration’s Office of Regulatory Affairs (ORA) is the lead office for all agency field activities. ORA inspects regulated products and manufacturers, conducts sample analyses of regulated products and reviews imported products offered for entry into the United States. In pursuit of its mission, ORA also works with its state, local, tribal, territorial and foreign counterparts.
OtisMed Corporation, former CEO plead guilty for distributing FDA-rejected cutting guides for knee replacement surgeries FDA resolves criminal and civil actions against Main Street Family Pharmacy California seafood company to halt production until FDA documents correction of unsanitary practices FDA takes enforcement action against Michigan sandwich company