Week 4 Flashcards
FDA inspectors can
Can conduct warrantless inspections of the premises of regulated industries
Factory inspection act of 1953
FDA need only present credentials and written notice of
inspection (Form 482)
Warning letter
Recommendations on steps needed to meet compliance
Created by FDA policy
Seizure
Only if safety is in question
Requires warrant from distinct court
US marshals seize the product
If seized: violaters can
Take no action (product destroyed)
Challenge in court
Work with FDA to fix the product
Detention
No warrant necessary
FDA can hold product
Need reason to believe the food is adulterated
Recalls
Mostly are voluntary
Can compel w/o a court order
Import refusals and alerts
Must pass through customs and FDA
Other actions
Restraining orders and injunctions
Suspension of facility registration
Adulteration
Food that contains any added poisonous or other added deleterious ingredient, which may render such and article injurious to health
Aesthetic adulteration
Intentional
Indirect
Food that may be held in insanitary conditions and may be contaminated
Indirect hazards
Health hazards
Visible contaminants
Natural or unavoidable defects
Economic adulteration
Marketing a product as containing ingredients it does not possess, or are not of the marketed standard
US vs lexington mill and elevator
FDA must show a significant possibility of harm to consumers
US vs 1232 cases of american beauty brand oysters
FDA must show that a naturally occurring substance could cause injury under normal use but also comply that removing the substance not create an effective ban of the food
