Inspections, Compliance, Enforcement, and Criminal Investigations
4-2 - UNTITLED LETTERS
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.
Center concurrence is required prior to issuing Untitled Letters unless direct reference has been granted.
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.
- 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.
- Updating Firm Profile Status in FACTS
When a profilable firm (i.e., domestic or foreign drug, biologics, or medical device facility) undergoes a Current Good Manufacturing Practice (CGMP) or Quality System (QS) inspection, the inspected profile classes should be updated by the action office (i.e., the district for domestic inspections or the district and the center for foreign inspections) at each stage in the review process. When an Untitled Letter is issued as a result of the inspection, the date and type of letter issued should be entered in the Remarks field for the relevant profile classes. For profile procedures, see IOM Exhibit 5-14 or the DCIQA intranet page.