Under section 415(b) of the FD&C Act, if FDA determines that food manufactured, processed, packed, received, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA may by order suspend the registration of a facility that:
• Created, caused or was otherwise responsible for such reasonable probability; OR
• Knew of or had reason to know of such reasonable probability AND packed, received or held such food.
