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FDA untitled letters

FDA’s enforcement letter for violations that don’t rise to warning-letter level. Read what the agency cited and what it asked for.
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What an untitled letter is, and why it matters

An untitled letter is an FDA enforcement letter for violations that the agency does not consider serious enough for a warning letter. It is called “untitled” because it carries no “Warning Letter” heading. FDA sends them after inspections (often of compounding pharmacies, outsourcing facilities and drug makers), after records requests and after reviews of promotional material.

Like a warning letter, it lists the violations FDA found, often with the 21 CFR section, and asks for a written reply, usually within 15 or 30 working days. Unlike a warning letter, it does not warn of enforcement action without further notice, but repeat problems often lead to one.

For quality teams, buyers and investors, an untitled letter is an early signal: it shows where FDA saw problems at a site before they became a warning letter. The firm’s reply shows how it answered.

What’s inside an untitled letter

The parts you will find in almost every one, and what each tells you.

  1. Letterhead and date

    The issuing FDA office, date, delivery method and, often, a case or reference number.

  2. Addressee

    The firm and the person responsible, such as the owner, CEO or pharmacist-in-charge.

  3. Basis for the letter

    The inspection dates and the Form 483, or the records request or review that led to it.

  4. Violations

    Each violation with the evidence and, where given, the regulation.

  5. What FDA asks

    The corrections expected and the written reply, usually within 15 or 30 working days.

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Questions

What is an FDA untitled letter?

An untitled letter is an FDA enforcement letter for violations that don’t rise to warning-letter level. It has no “Warning Letter” heading, lists what FDA found and asks the firm to reply in writing with its corrections.

What is the difference between an untitled letter and a warning letter?

Both are advisory letters from FDA. A warning letter is for violations of regulatory significance and warns that FDA may act without further notice. An untitled letter is for less serious violations and carries no such warning, but FDA can escalate if problems continue.

Does a firm have to answer an untitled letter?

FDA asks for a written reply, usually within 15 or 30 working days, describing what the firm has done to correct the violations and prevent them from recurring.

Are firm replies to untitled letters available?

Yes, where we hold them. A reply is listed next to the letter it answers on the document page and on the firm page.

How much does an untitled letter cost on FDA Intel?

$99 per letter and $199 per reply, paid by card with no subscription. Your first Form 483 or letter is on us.

See what FDA flagged before it became a warning letter.

$99 per untitled letter. Your first Form 483 or letter is on us.

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