When filing Prior Notice in advance of the importation into the U.S. of food, FDA has identified the most common errors as:
1) Ultimate consignee is incomplete or wrong;
2) Manufacturer name and address is incomplete or wrong;
3) FDA product code does not match the actual product imported; and
4) The Prior Notice does not report all the food imported.
In terms of enforcement, FDA will elect among the following options:
A) Informed compliance;
B) Civil penalty;
C) Refused Admission; and
D) Injunction and/or debarment.
The rule of thumb is you need to break the product out and report it separately for Prior Notice purposes if there is a different product code, manufacturer or package size.