Time-criticalWarning-letter response · 15 working days
An FDA warning letter gives you fifteen working days to respond. What the agency wants is specific: every cited claim corrected everywhere it appears, and evidence the correction is systematic, not cosmetic.
We produce the claims half of that response. Counsel handles the agency.
The 15-working-day window
The window is fifteen working days and it is the same for everyone. What differs is what goes in the reply.
Send it with your URLs. The sweep starts the same day. Nothing else is needed from you while counsel is engaged.
Attach the letter as a PDF or a photo of each page, whatever you have. Scope is confirmed in writing before any charge.
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.
Every cited claim mapped to the exact statute it fails, 21 U.S.C. §343(r), 21 CFR 101.93, FTC Act §5, and rewritten compliant. Your response can say corrected, not just deleted: the copy that sells survives wherever the rules allow it. The corrective-action section of your response letter is drafted, ready for counsel to file.
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.
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 what you hold is a dated record rather than a reconstruction.
Your warning-letter dashboard
Upload the letter or send its fda.gov link. Every claim it quotes is ruled with its corrective action, your other copy is swept for the same claims, and the claims section is drafted for your counsel.
Your company Letter being ruled
Your warning letter The letter on fda.gov, linked
FDA asks for a written response within 15 working days. The count runs from the letter’s date. If you received it later, count from the day it arrived. Your counsel files the response.
Each one ruled, with the corrective action and the standard it fails.
RuledListing, site, ads, emails and labels swept for every quoted claim.
SweptThe claims section of your response, drafted for your counsel to review and file.
DraftedA simplified preview. Ask about a claim as you rewrite, and each rewrite is re-checked. The pharmacist signs on request.
Price and scope
Both include 30 days of monitoring.
Standard
$5,000
The full file in three business days.
Rush
$10,000
The same file in 24 hours.
Confirmed in writing before any charge. 30 days of monitoring included.
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.
Start now
Send the company name, your work email and a link to the letter. We reply the same business day with scope and a fixed price. Prefer email? audit@claimsverified.org with the letter attached works too.
Send the letter
Same-day reply with scope and a fixed price.