FDA warning letter

An FDA warning letter is an official message from the <a href="/facts/United_States/P0sCdLe5">United States</a> <a href="/facts/Food_and_Drug_Administration/rCEnh9WB">Food and Drug Administration</a> (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity.
The FDA defines an FDA warning letter as:

<blockquote>... a correspondence that notifies regulated industry about violations that FDA has documented during its <a href="/facts/Inspections/VIHSpFXp">inspections</a> 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 <a href="/facts/Federal_Food%2c_Drug%2c_and_Cosmetic_Act/2WIHtPjC">Federal Food, Drug, and Cosmetic Act</a> (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for <a href="/facts/Infraction/1cMHzM78">violations</a> 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 <a href="/facts/Regulatory_compliance/1pIoTaB7">compliance</a> with the Act.</blockquote>
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 <a href="/facts/Voluntary_compliance/Yo9QxAKp">voluntarily comply</a> with the law. When the FDA observes a deviation from acceptable practice, they give the organization an opportunity to take voluntary and prompt <a href="/facts/Corrective_action/bWydduL4">corrective action</a> before initiating 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 <a href="/facts/Form_FDA_483/twLG75eu">Form FDA 483</a> that supports the alleged violations, the <a href="/facts/Regulation_of_food_and_dietary_supplements_by_the_U.S._Food_and_Drug_Administration/yxFrczR2">Establishment Inspection Report</a> (EIR), and any written response from the firm.

FDA warning letter open-in-new

FDA warning letter