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The Anatomy of a Warning Letter, Part One: A Primer

Warning Letter Factoids

FDA’s position is that Warning Letters are issued only for violations of regulatory significance. Significant violations are those violations that may lead to enforcement action if not promptly and adequately corrected. A Warning Letter is the agency’s principal means of achieving expeditious voluntary compliance with the Federal Food, Drug and Cosmetic Act.

The Warning Letter was developed by the Agency to correct violations of the statutes or regulations.

Responsible officials in positions of authority in regulated firms have a legal duty to implement whatever measures are necessary to ensure that their products, practices, processes or other activities comply with the law. Under the law, such individuals are presumed to be fully aware of their responsibilities.

A Warning Letter is informal and advisory. It communicates the agency’s position on a matter, but does not commit FDA to taking enforcement action. For these reasons, FDA does not consider Warning Letters to be final agency action. Further regulatory and/or legal actions can ensue.

This is important. There are times when issuing a Warning Letter is not appropriate, nor is it timely enough, due to potentially high-risk situations. In these cases, a Warning Letter is not a prerequisite to taking enforcement action. Examples of situations in which FDA will take rapid enforcement action without taking the time (and resources) to issue a Warning Letter:

1. When the violation reflects a history of repeated or continual conduct of a similar or substantially similar nature, during which time the individual and/or firm has been notified of a similar or substantially similar violation

2. When the violation is intentional or flagrant

3. When the violation presents a reasonable possibility of injury or death

4. When the violations are intentional and willful acts

5. When adequate notice has been given by other means and the violations have not been corrected or are continuing  

Warning Letters can be issued at the discretion of the district director without concurrence from the Center for Devices and Radiological Health (CDRH), except in specific program areas that require prior center concurrence.

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