A business may petition FDA for exclusion from an Import Alert by demonstrating evidence of compliance that overcomes the apparent violation detailed in the Alert. A common misconception is that a facility is excluded from Import Alert after five consecutive non-violative shipments are released by FDA. This is only a small component of a larger process involving other, potentially extensive requirements.
The specific requirements for a petition vary, and are outlined in the guidance issued with an individual Import Alert. These may include documentation of revised food safety plans, revised labeling or formulations, changes implemented in the manufacturing process, or documentation of compliance with a government agency regulating food in the facility’s home country.
Many businesses can be intimidated by the extensive requirements of an Import Alert petition. These businesses may remain under Import Alert, facing DWPE and difficulties satisfying the requirements of an importer’s FSVP, even if they are not in violation of the specified regulations at the time. Despite a solution to the problem, some businesses might have no idea how to begin a petition.
