What Is an FDA Warning Letter?

The Food and Drug Administration is responsible for protecting public health. The FDA uses several processes to evaluate companies and their products. The FDA warning letter is one of the early, informal, advisory steps used by the FDA when a violation is suspected.

Features

• The FDA is an agency within the U.S. Department of Health and Human services. It protects public health by working to ensure the safety of drugs, vaccines, biological products, medical devices, food supplies, cosmetics, dietary supplements and tobacco products.

Function

• FDA warning letters are informal, advisory letters sent to companies or clinical investigators. Warning letters are used to inform the recipient of the FDA's position on a matter. Warning letters do not commit the FDA to taking enforcement action.

Corrections

• Warning letters offer the recipient a chance to correct the violations. The FDA requires recipients to take prompt and adequate action. It is not enough to plan corrective action; companies must show the corrective action was taken.

Considerations

• The FDA will conduct a follow up evaluation to assess for corrective action implemented in response to the warning. If the violations have all been addressed and corrective actions have been verified, the FDA will not seek further corrective action. Warning letters are only informal advisories of violations, not a final action. Companies are not penalized for receiving a warning letter. Final action against a company occurs only if the violations are not addressed.