Untitled Letters & Advisory Actions
What is an untitled letter?
An untitled letter (sometimes called a "notice of violation" or "advisory letter") is an FDA communication — less severe than a warning letter — that notifies a company of a violation that does not meet the threshold for a warning letter. Untitled letters are commonly used for:
- Promotional violations — labelling or advertising that makes false or misleading claims, but where the violation is less egregious
- Minor regulatory violations — technical non-compliance that does not present a direct safety risk
- First-time or inadvertent violations — where FDA prefers to alert the company rather than escalate
Untitled letter vs warning letter
| Feature | Untitled Letter | Warning Letter |
|---|---|---|
| Severity | Lower | Higher |
| Publicly posted on FDA website | Yes (typically) | Yes |
| Formal response required? | Usually — but less formal | Yes — within 15 business days |
| May escalate to warning letter? | Yes, if not corrected | May escalate to injunction/seizure |
| Typically used for | Promotional violations, minor labelling issues | QMSR violations, MDR failures, serious non-compliance |
Advisory actions
Beyond untitled letters, FDA has a range of informal advisory tools:
- Meeting with FDA — FDA may request a meeting to discuss compliance issues before taking formal action
- Regulatory meeting letter — documents the outcome of a compliance meeting
- Compliance letter — similar to untitled letter; acknowledges an identified problem and requests correction
- Courtesy letter — informs a company of a potential issue proactively, without asserting a violation
Responding to an untitled letter
Even though less formal than a warning letter, an untitled letter should be taken seriously:
- Review the identified violation carefully
- Assess whether the violation is accurate — if not, document your disagreement professionally
- Implement corrections — stop the violating activity (e.g., withdraw promotional material)
- Respond in writing within a reasonable time (typically 30 days) describing your corrective actions
- Document the response — failure to respond can escalate to a warning letter