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4-2 - UNTITLED LETTERS
4-2-1 - Policy
4-2-2 - Tracking
4-2 - UNTITLED LETTERS
4-2-1 - Policy
An Untitled Letter cites violations that do not meet the threshold of regulatory significance for a Warning Letter. Therefore, the format and content of an Untitled Letter should clearly distinguish it from a Warning Letter. For example: - 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. Also, see Exhibit 4-1, the agency’s “Procedures for Clearing FDA Warning Letters and Untitled Letters.” All agency components responsible for issuing Warning Letters and Untitled Letters must follow these procedures.
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- Identification Of Untitled Letters
All Untitled Letters must be entered into the Compliance Management System (CMS); whether they are generated by a district or center, and whether they are approved and issued or not. Every Untitled Letter that is issued should bear the CMS-assigned number or a sequential code number assigned by the issuing district or center. If a district or center assigned number is used, this number should be recorded in CMS to facilitate tracking.
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