Unless expressly exempted by law, virtually every food facility, both in the United States and abroad, that is subject to FDA’s Bioterrorism Facility Establishment registration, must establish and implement an adequate HARPC food safety plan. The owner, operator or agent in charge of the facility must have their HARPC plan available and ready to present to FDA after receiving an oral or written request. The plan must be correct, or the firm could find itself the target of a public FDA Letter or Import Alert.
