Thats because a rule like this is "secondary" legislation that hangs off some piece of "primary" legislation. Primary is created by Congress, secondary is creat

Thats because a rule like this is "secondary" legislation that hangs off some piece of "primary" legislation. Primary is created by Congress, secondary is created by government agencies as specified by the primary legislation. Somewhere there is a piece of primary legislation saying that the FDA can make rules regarding the manufacture and sale of some defined class of items. The preamble to the FDA rule probably mentions it. That primary legislation will lay down the penalties for failing to comply. The problem is that the primary legislation doesn't relate the severity of the crime to the penalty, it just prescribes the maximum penalty. Since this has to cover anything up to selling baby milk adulterated with melamine, you are talking vast fines and years or decades in prison. In theory this could apply for failing to maintain proper paperwork on just one occasion. In practice the FDA gets to decide how serious your crime is, although it does have to be rubber-stamped by a judge, and if they wanted to do more than close you down then normal criminal evidence rules would apply.