Under FSMA, the FDA can suspend a food facility's registration if they determine what condition?

• A. Food safety is questionable
• B. Food has a reasonable probability of causing serious adverse health consequences or death
• C. The facility failed to maintain records
• D. The facility created/caused/was responsible for the problem and knew or had reason to know of the reasonable probability

Answer: (D)

The key idea is that FDA’s authority to suspend a food facility’s registration targets those facilities that caused or contributed to a problem and that knew or had reason to know there was a reasonable probability the food could cause serious harm. In FSMA, the suspension power is not just about a dangerous product in general; it’s about the facility’s own conduct and awareness of risk. If a facility created or caused the issue and was aware (or should have been aware) that there was a real chance the food could cause serious health consequences or death, the FDA can suspend that facility’s registration to prevent further unsafe product from entering the market.

That’s why the best choice is the one that combines responsibility for the problem with knowledge of the risk. The other statements don’t fit because they either describe risk in general without tying it to the facility’s conduct, or focus on procedural failures (like recordkeeping) or vague assessments of safety rather than the culpable role and awareness required for suspension.