FDA can order suspension of a food facility’s registration when:
1. FDA determines that food manufactured, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals (SAHCODHA); and
2. That facility:
a. Created, caused, or was otherwise responsible for that reasonable probability of SAHCODHA; or
b. Knew of, or had reason to know of, the reasonable probability of SAHCODHA, and packed, received, or held such food (section 415(b) of the FD&C Act).
