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Audits
Compliance
Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.
Class II
Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.
Class III
Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.
A recall which is currently in progress.
Completed
A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections
Terminated
A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.
Registration
Food, drug, and medical device suppliers are required to register with FDA. Shipments of products from unregistered suppliers are subject to detention at the U.S. border.
Food Suppliers that manufacture, process, pack, or store human or animal food for U.S. consumption are required to register with FDA.
Drug Establishments that manufacture, prepare, propagate, compound, or process drugs in the U.S. or that are offered for import into the U.S.
Medical Device Establishments that produce and distribute devices intended for use in the U.S. are required to register with FDA.
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The FDA ComplyHub displays Inspection Classifications, Warning Letters, and Refusals published after October 1, 2011.
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