The US Food and Drug Administration’s (FDA) has issued draft guidance proposing that devices be deemed adulterated and refused entry to the US market if companies refuse to allow inspections of their facilities without adequate justification. Under current FDA policy, only drugs can be deemed adulterated if FDA inspectors are barred at the door.
The draft align with an update in the law under the FDA Reauthorization Act (FDARA), which requires devices also be deemed adulterated and refused entry for staff that block FDA inspections.
The draft guidance defines the types of actions that constitute unreasonable conditions for delaying denying or limiting an inspection.
The revised draft is almost identical to the 2014 final guidance on circumstances for delaying or denying an inspection, except that it incorporates the FDARA provisions. The law also required FDA to issue final guidance outlining the circumstances that constitute unjustified refusals a year after issuing a draft guidance…
