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Warning Letters

Most Warning Letters are based on an investigator's findings made during a site inspection. They are usually summarized in an inspectional observation (FDA Form 483).

A Warning Letter is the written communication from the FDA (US. Food and Drug Administration) notifying an individual or firm, that the agency considers one or more products, practices, processes, or other activities to be in violation of the FFDC Act, or other acts, and that failure by the responsible party to take appropriate and prompt action to correct and prevent any future repetition of the violation, may result in administrative and/or regulatory enforcement action being taken without further notice.

A Warning Letter is semi-formal and advisory. It communicates the agency's position on a matter, but it does not commit the FDA to taking enforcement action. For these reasons, the agency does not consider Warning Letters to be a final agency action for which FDA can be used.

The Warning Letter was developed and initiated to correct violations of the statutes or regulations. Also available to the agency are enforcement strategies that are based on the particular set of circumstances at hand and may include sequential or concurrent FDA enforcement actions such as recall, seizure, injunction, administrative detention, and/or prosecution to achieve correction.

Use of the Warning Letter and the prior notice policy, are based on the expectation that a majority of individuals and firms will voluntarily comply with the law. The agency's position is that Warning Letters should only be issued for violations of regulatory significance; i.e., those violations that may actually lead to enforcement action if not promptly and adequately corrected.

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