TIME-CRITICAL · WARNING-LETTER RESPONSE

A letter arrived. The clock is running.

Every cited claim corrected everywhere it appears, rewritten to the strongest wording the standard allows so the copy that sells survives. An FDA warning letter gives you fifteen working days to respond, and the agency wants evidence the correction is systematic, not cosmetic.

We produce the claims half of that response. Counsel handles the agency.

Send my letter now Talk it through first, 15 min
Full file in 3 business days24-hour rush availableWorks with your counselWe reply the same business day
Your 15-day windowCOUNTER
Response due
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Enter the date to see your deadline.
$5,000 · 3 business days24-hour rush $10,000
Estimate only. Weekends and US federal holidays excluded. Your counsel confirms the date.
THE RESPONSE FILE · 3 PARTS

A deleted claim loses the sale it made. A corrected one can keep selling.

Answer the letter with evidence. In 15 seconds: every cited claim matched to the published rule it breaks, with wording the standard allows for your response.
01
The sweep

Every cited claim and its near-variants, found everywhere they appear.

02
The corrections

Each claim matched to the published rule it breaks, with replacement wording.

03
The signed file

Replacement wording for each claim, for your counsel’s response. Ready on day 3.

THE 15-WORKING-DAY WINDOW

Use the fifteen days to prove the fix, not promise it.

The window is fifteen working days and it is the same for everyone. What differs is what goes in the reply.

DAY 0
Send us the letter

Send it with your URLs. The sweep starts the same business day. Attach the letter as a PDF or a photo of each page, whatever you have. Scope is confirmed in writing before any charge.

BY DAY 2
The full sweep

Every claim the letter cites, found everywhere it appears: your listing, your site, ads, emails, labels, backend keywords. Plus the claims it did not cite that sit in the same statutory territory as the ones it did.

BY DAY 3
Replacement wording ready, file delivered

Each cited claim matched to the published rule it breaks (21 U.S.C. §343(r), 21 CFR 101.93, FTC Act §5), with replacement wording for each one. Your response can say corrected, not just deleted. Your counsel decides what goes in the response and files it.

YOUR REPLY
The signed exhibit

A pharmacist-signed evidence file, statute citations included, for every claim you keep. Your counsel attaches it as proof the review was systematic, the difference between a response and a promise.

AFTER
After the reply

FDA’s published position is that failing to promptly correct violations can result in legal action, and that corrections are verified before a letter is closed out. 30 days of monitoring is included: we re-scan the corrected surfaces and date every change, so you hold a dated record rather than a reconstruction.

YOUR WARNING-LETTER DASHBOARD

The countdown, the claims and the fix, in one view.

Your companyWarning-letter response 11 working days left Sample data
Your warning letter
Findings and fixes
Claims review for counsel
Ask about a claim
Claim memory
Change history
Every claim the letter quotes
Each one ruled, with the corrective action and the standard it fails.
Ruled
The same claim in your other copy
Listing, site, ads, emails and labels swept for every quoted claim.
Swept
Claims review for counsel
The claims review and replacement wording, for your counsel to use in the response.
Drafted

A simplified preview. Ask about a claim as you rewrite, and each rewrite is re-checked against the same standards. The pharmacist reviews on request.

PRICE AND SCOPE

The fifteen days do not pause.

Standard
$5,000
The full file in three business days.
Rush
$10,000
The same file in 24 hours.

Inquiry only, for a letter from the FDA or the FTC. A fixed fee, confirmed in writing before any charge. Both include 30 days of monitoring. A suppressed Amazon listing is Listing Rescue, $1,000 in 48 hours.

We are not a law firm and do not represent you before the FDA. We produce the claims review and corrections your response is built on. Your counsel owns the reply and files it. Review of marketing language only, not legal advice, product testing, or facility-compliance (CGMP) work. Findings are our opinion under the published Claims Verified standards.

Send the letter
A reply the same business day, with scope and a fixed price.
Prefer email? audit@claimsverified.org with the letter attached works too.
© 2026 Claims Verified Privacy Terms Unsubscribe Reviewed by a licensed pharmacist Published from Toronto · 109 current standards · every figure recomputed from the scan databases before each deploy