15 / 18
U.S. Food and Drug Administration (FDA) Regulations
13
•
Violations common or widespread in certain region.
For example filthy dried or pickled finfish and vegetable
protein products that contained melamine
b) Red List Import Alerts
•
Based on the nature of the violation or history of the
company. For example, misbranded seafood, foods
containing illegal and/or undeclared colours, and food
products due to Salmonella
DETENTION WITHOUT PHYSICAL
EXAMININATION (DWPE)
Under DWPE, shipment will be detained without an inspector even
looking at it. It works under the premise that the products appear
violative based on a history of violation. However, it is NOT an
automatic refusal. The manufacturer or importer must present
evidence to FDA that the product is NOT violative in order to get a
shipment released from detention. This process will repeat for ALL
shipments for as long as the import alert is in effect.
A firm will remain subject to DWPE unless it provides evidence to
FDA that it is no longer at risk. Evidence is provided in the form of
a petition sent to Division of Import Operations (DIO) to request
removal. It may be 100+ pages in length and requires extensive
documentary evidence.
PETITION
a. Requirements
•
Corrective Actions
where documentary evidence that
the problem has been corrected or prevented. It will
vary depending upon the circumstances such as Food
Safety Plan revisions, HACCP plan revisions, Change
of suppliers, Label revisions, Lab analyses of every lot,
etc.