FDA Letters to the industry (Warning Letter and Untitled Letter)

FDA Letters to the industry (Warning Letter and Untitled Letter)

If a person or firm violates the Federal Food, Drug and Cosmetic Act (FD&C Act), FDA may give them an opportunity to take voluntary and prompt action to correct the violation before FDA initiates an enforcement action. FDA will issue either a Warning Letter or an Untitled Letter, depending upon the nature of the violation. FDA uses Warning Letters for violations that may lead to enforcement action if they are not promptly and adequately corrected. FDA uses Untitled Letters for violations that are not as significant as those that trigger warning letters. Unlike a Warning Letter, an Untitled Letter does not include a statement warning that failure to promptly correct a violation may result in an enforcement action. An Untitled Letter cites violations that do not meet the threshold of regulatory significance for a Warning Letter. An Untitled Letter differs from FDA warning letter in following aspects.  The letter is not titled    The letter does not include a statement that FDA will advise other federal agencies of the issuance of the letter so that they may take this information into account when considering the awarding of contracts. The letter does not include a warning statement that failure to take prompt correction may result in enforcement action. The letter does not evoke a mandated district follow-up. The letter requests (rather than requires) a written response from the firm within a reasonable amount of time (e.g., "Please respond within 30 days"), unless more specific instructions are provided in a relevant Compliance Program. Any appropriate agency compliance official may issue an Untitled letter. Warning Letter VS Untitled Letter Warning Letter Untitled Letter Does not represent official FDA enforcement action Does not represent official FDA enforcement action Includes statement about potential enforcement action Does not include statement about potential enforcement action Intended to induce voluntary compliance with regulations Intended to induce voluntary compliance with regulations Is the most serious communication before the FDA takes enforcement action Less serious than warning letter (still serious!)

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