Amazon requested FDA compliance records or removed your listing? We review the product, claims, labels and documents, then prepare a response to the exact request and manage the appeal.
Founder-led review. Most first replies within about an hour.
Last verified as of .
Founder-led enforcement expertise backed by executive leadership and specialist teams in Seller Central.
Founder, ASA Compliance Group · International speaker on Amazon enforcement and reinstatement
When your Amazon account or listings are suspended, every moment counts, and genuine expertise matters. Or Shamosh, founder of ASA Compliance Group, has spent over 10 years mastering the complexities of Amazon’s policies, compliance guidelines, and seller reinstatements. His LL.B. background informs how he reads Performance Notifications and frames compliance strategy; complex matters still run through ASA Compliance Group’s in-house legal department and outside counsel when required. He has led work across 5,500+ cases. His work spans seller account suspensions, listing appeals and compliance cases.
Or regularly shares his knowledge at seller conferences and webinars worldwide, including Prague March 2025, Sofia April 2025 and April 2026, Warsaw May 2026, with an upcoming UK appearance in October 2026. See conference appearances, explore seller webinars, read the restricted keywords guide, or see client stories in Testimonials.
AmazonSellersAppeal is operated by ASA Compliance Group, with dedicated appeal, legal, IP, and compliance teams in Seller Central. Michael Gourin and Smadar Popovski, alongside Or, lead intake and case operations; specialist staff join when your Performance Notification requires it.
Or Shamosh · Founder & CEO
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Runs Performance Notification review, POA execution, Seller Central follow-ups, and escalations with disciplined sequencing.
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Most of these are not sellers offering unlawful products. They are ordinary goods whose paperwork or wording placed them somewhere unintended.
The product genuinely falls in a regulated category and the record that category requires is missing, belongs to someone else, or was never obtained. This is the branch where the answer may be that the product cannot be offered until something real changes.
Establish the category first from the product and its intended use. Working backwards from the document you happen to hold is how a case acquires a second problem.
The listing says approved, cleared or certified when the record does not support that word. Sometimes the seller believed it; registration certificates are often presented by suppliers in ways that invite exactly this reading.
The most common branch, and the most fixable. An ordinary product acquires a regulated intended use because of what the listing says it does. The physical item never changed; its described purpose did.
Intended use can be communicated in the title, bullets, images, enhanced content, video, backend terms, packaging, inserts, instructions or linked marketing. Which is why editing the title alone leaves the classification exactly where it was: see medical claims compliance for that analysis in full.
The record is genuine and belongs to a different legal manufacturer, model, product code, intended use, applicant or address. Suppliers share documents freely and the coverage rarely travels with them.
Where you rely on another entity's record, the file needs the authorisation and the model-to-listing mapping as well as the record itself.
Language describing diagnosis, treatment, mitigation or prevention of disease is the wording that most often moves a product, and it does not require the word medical to appear anywhere. A structure or function statement may or may not have that effect: it depends on the product category, the intended use and the exact wording, so read the three together rather than treating any such phrase as decisive.
Where the same language is printed on the unit, its packaging or its instructions, a catalog edit leaves the underlying position untouched. The physical and the digital both have to reach a compliant state, and they are corrected by different means.
AmazonSellersAppeal by Or Shamosh reviews your FDA compliance notice and evidence, then manages your case in Seller Central.
We review the FDA-related notice, product category, intended use and labeling to identify the requirement Amazon cited.
We check the relevant regulatory records and listing claims, then prepare the documentation or corrections needed for the response.
We manage the Seller Central submission, verify any relevant listing corrections and handle further document requests, revisions and follow-ups.
Strategy, evidence, appeal writing, submissions and unlimited follow-ups and revisions within the agreed case scope.
Amazon seller enforcement is our daily work. Amazon Sellers Appeal has handled account, listing and compliance cases across global marketplaces.
* Historical results across ASA Compliance Group-managed enforcement cases. Last verified as of .
Real names and quotes from clients we’ve helped through reinstatement. Every case has its own timeline and details.
Other firms failed
“One of the greatest messages an Amazon seller can receive! I tried 2 other firms that both failed miserably and wasted about 5-6 weeks. Or fixed it in < 48hrs.”
Suspended 6 weeks, then deactivated
“My account had been suspended for more than 6 weeks with 4 failed attempts. Then it was completely deactivated. I hired Or Shamosh and within 3 days it was reactivated. Add me to that recommendation list.”
Reactivated in 24 hours
“Or was the only one who offered a solution to resolve everything without removing all the products from Amazon warehouses. In less than 24 hours after the appeal, my account was reactivated with all products available for sale.”
Account suspended
“My Amazon seller account was suspended and then a miracle. I paid Mr Or Shamosh who got me back on, so quick only 5 days later I was back!! I highly recommend him. He is brilliant, honest and genuine.”
Pesticide listing
“HUGE shoutout to Or Shamosh for his help with my PESTICIDE suspension. I fought them myself for a month with no results. Reached out on Friday. My listings were live again earlier TODAY. LESS THAN A DAY!”
Listing complaints
“Shout out to Or Shamosh for helping me get one of my listings back online after it got taken down due to customer complaints! Thanks buddy.”
Hijacker removed
“I had a hijacker who really didn't want to leave. When Or sent me his organized method and we acted together, he dropped off my listing after a week and a half. I highly recommend him.”
Product reinstated
“After a month of ongoing work, the product was finally reinstated. Or was available at any moment, a precise professional, and courteous.”
Hijacker resolved
“A hijacker lowered my price by 40%. I turned to Or Shamosh who guided me through this process. Another week went by and the issue was resolved. Amazing service, patience, and he was available at all times.”
Listing policy
“A magician! I highly recommend Or for anyone who needs help with Amazon policy and listing reinstatement. He is patient, attentive, meticulous, and most importantly, professional and fast!”
Patent dispute
“A competitor wrongly accused me of patent infringement. Or Shamosh helped me fix this problem very quickly and professionally! I'm more than happy with his service and communication.”
“Shamosh is a true professional and WIZARD! Very kind, super responsive, and extra helpful. He literally saved my business! God bless you both.”
Patent infringement
“My listing was reported for PATENT infringement. Within 3 working days my listing was back online. Even after reinstatement, I had relisting issues. He sent another appeal and within 1 hour it was all back online.”
Account review
“Amazon notified me my account was under review. I immediately contacted Or Shamosh, who worked tirelessly all week. Within a short time, my account was reinstated. If you encounter issues, know you have a professional on your side.”
Trademark claim
“A competitor filed a false Trademark claim. I had a thorough, well-written appeal the next day. My appeal was accepted and within a few days my listings were back up and live. I am beyond grateful.”
Patent complaint
“Or Shamosh is AMAZING. Thank you my friend for helping me to reinstate my listings. He did an awesome job for appealing my patent complaint. You're the MAN.”
Adult flag
“Amazon incorrectly placed an 'Adult' flag on my listing. I fired off the emails in the morning and just half hour later got a reply from Amazon saying they have lifted the flag!!!! I'm beyond happy.”
Account reinstated
“Thanks so much to Or Shamosh for reinstating my account!! You have done an amazing job and were able to get me selling again in no time! Definitely recommend his services!”
Pesticide tag
“I'd been struggling for about two months due to an incorrect pesticide tag. After almost 10 weeks of trying myself, Or helped me get the listing reinstated in less than a week. Without his help, I'm not sure if I'd ever have solved it.”
Six short videos from sellers who worked with ASA Compliance Group through reinstatement. Every case has its own timeline and details.
6 client video stories
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ASA Compliance Group operates Amazon Sellers Appeal. On FDA files we reconcile product, claims and official record, then either correct the catalog or document the product status that already supports it. We are not regulatory counsel.
There is no single FDA document problem. Amazon may be testing whether the product is a drug, a medical device, a cosmetic, a food, a supplement or something else; whether the registration, listing, clearance, approval, labelling or documentation that category requires exists; whether an approval claim is accurate; or whether the listing itself moved the product into a regulated category.
So the first job is narrow and unglamorous: read what the notice actually asked for. A response that supplies a genuine document answering a different question is the commonest way these cases stall, and it can repeat for months.
The vocabulary, because these six are routinely used as if they meant the same thing:
For medical devices, an establishment registers with FDA and a device is listed. Both say a facility or product is on record. Neither says anything was reviewed. Other FDA-regulated categories use different registration, listing, application or authorisation systems, so read which one your notice names.
Different review pathways with different evidence behind them. Both are decisions about a specific product, not a company.
An exemption removes one requirement under stated conditions. Compliance is meeting whatever still applies, which is usually more than nothing.
Common Amazon notices refer to 510(k) clearance or exemption for a medical device, an NDC or drug listing, or a New Drug Application. These records are not interchangeable, and an NDC listing does not mean FDA approval - the directory says so itself, stating that inclusion does not indicate the products are FDA-approved.
FDA states the first distinction itself, in its own guidance on registered versus approved, and describes what registration and listing are. Amazon's side sits in restricted products and its document requirements. Where the finding is eligibility rather than classification it belongs with restricted products, and where it is testing or an incident it belongs with product safety compliance. This page is diagnostic: regulatory conclusions depend on product facts and jurisdiction, and belong with qualified review.
Reviewers are matching a specific requirement against a specific product. Genuine documents fail that match constantly.
An establishment registration or database listing sent to answer a request for clearance or approval. They are different records.
A record belonging to a different manufacturer, model, applicant or intended use, with no authorisation and no mapping to the product sold.
The obvious phrase removed while the same intended use remains in bullets, images, enhanced content, video, backend terms, packaging or inserts.
The product called a cosmetic or a wellness item while its own claims describe diagnosis, treatment or prevention.
Screenshots, partial records or documents with anything altered. Originals are checkable; edits end the conversation.
The catalog corrected while the unit, its packaging and its instructions still carry the claim that created the classification.
A focused appeal connects your notice with verifiable records. Here is what we review: product classification, labeling, claims and FDA-related records.
Record the exact request and any rejection reasons, the listing, the product type, the category and the marketplace. Then describe the product physically: what it is made of, how it works, whether it has a powered function, a delivery mechanism, a measurement or an active ingredient. Regulatory category follows from function and intended use, and both are established from the object.
Photograph the whole label and packaging, the instructions, the warnings, the ingredients or materials, the model numbers and the manufacturer or importer identity. What the unit says about itself is often decisive and is frequently the part nobody has looked at.
Capture every surface that could carry intended use, current and historical, because the classification may have been driven by content that is no longer visible:
Mark each as compliant, to be corrected, or defensible. A claim that is accurate and permitted for a genuinely regulated product should not be deleted in a panic; removing legitimate content can weaken a correct classification argument.
Then the official evidence appropriate to the category: the registration or listing, the clearance, the approval, the monograph status, the drug listing context, or the exemption basis, mapped to the exact manufacturer, model and intended use. Where you rely on another entity's record, add the authorisation and the mapping.
Say plainly what each record establishes and what it does not. A file that claims less and proves it reads far better than one that overstates and gets checked, and the checking here is against public databases.
Catalog corrections run through prepared, uploaded, processed and live-verified. Physical corrections have their own states, and inventory already produced does not change because a page did. Report each honestly, and see incorrect detail page for the catalog half.
Where the requirement is documentation rather than correction, Amazon's compliance submission route is the path, and the document requirements in its product-document rules decide whether what you send is usable at all.
If you are relying on a supplier's document, say whose it is. That single fact changes what the file needs, and discovering it late has cost cases weeks.
For sellers who already have the Performance Notification. Broader questions: full FAQ library.
Your case stays with one team for the evidence review, appeal, submissions and follow-ups.
Include what the product is and what it is for, photographs of the label and packaging, and any regulatory documents already sent. Four short steps. Or Shamosh reads every intake.
Or Shamosh · Founder and lead strategist
5,500+ enforcement cases since 2016. Every intake is personally assessed before acceptance.
Send what you have, including prior DIY or agency appeals. We say what is viable in writing before you commit.
Questionnaire
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If Amazon requested FDA documents or reclassified your product, start with the questionnaire.
For individual ASIN issues, explore listing reinstatement. For a different notice, browse all suspension types.
