FDA Warning Letter

An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) that it has found that a manufacturer or other organization has violated some rule in a regulated activity.

The FDA defines an FDA warning letter as:

"...a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act.

While the FDA generally determines violations through its own inspections, they can also issue one based on evidence from state personnel The FDA considers a warning letter informal and advisory. It communicates the agency's position on a matter, but does not commit the FDA to an enforcement action. For that reason, the FDA does not consider a warning letter a final action on which it can be sued.

The FDA expects most individuals, firms, and government establishments to voluntarily comply with the law. When the FDA observes a deviation from acceptable practice, they give the organization an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. A step in this process, depending on the nature of the violation, is to issue a warning letter, which also establishes prior notice.

The agency has a computer application called the Compliance Management System (CMS, or MARC-CMS).) that district offices use to electronically submit warning letter recommendations to FDA Centers. All district office must use the CMS to submit the warning letter recommendation, the Form FDA 483 that supports the alleged violations, the Establishment Inspection Report (EIR), and any written response from the firm.

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