Warning letter · Center for Drug Evaluation and Research (CDER)
FDA warning letter 728291 to OrderlyMeds LLC dba OrderlyMeds
Issued June 8, 2026. The letter alleges that a pictured label carries the OrderlyMeds logo, suggesting it is the compounder when it is not, and the site described its source as an FDA-licensed pharmacy, a designation FDA does not grant. It asks for a written response and it did not halt the business. The ledger record for OrderlyMeds passes S8.
The letter, as filed
Every line below is copied from the letter itself. The addressee and the address are the ones the agency prints in the header, which is the pair an attribution rests on.
| Number | MARCS-CMS 728291 |
|---|---|
| Issued | June 8, 2026 |
| Addressee | OrderlyMeds LLC dba OrderlyMeds |
| Address | 235 Ponce De Leon Pl., Suite M347, Decatur, GA 30030 |
| Recipient | Brian Spears, MD, Chief Medical Officer |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Subject | False & Misleading Claims/Misbranded (Telehealth) |
| Website reviewed | https://orderlymeds.com, reviewed in March 2026 |
| Sections cited | 502(a), 502(bb), 301(a), 301(c) of the Federal Food, Drug, and Cosmetic Act |
| Close-out letter | None on the index when the close-out column was last read. |
What it alleges
A pictured label carries the OrderlyMeds logo, suggesting it is the compounder when it is not, and the site described its source as an FDA-licensed pharmacy, a designation FDA does not grant.
The letter quotes 1 claim from the website it reviewed, reproduced here exactly as the letter prints it, including the agency's own elisions.
“FDA-licensed pharmacy.”
A quoted claim is evidence of what a page said when the agency read it. It is not evidence of what the page says today, and this site records the seller's current pages separately, on the seller record, with their own date.
The sections cited are 502(a), 502(bb), 301(a), 301(c). Section 502(a) makes a drug misbranded where its labeling is false or misleading, and section 502(bb) extends that to the advertising or promotion of a compounded drug. Both are labeling and advertising provisions.
How it was attributed
The entity, the street address and the named Chief Medical Officer in the letter all match what the seller prints in its own terms, privacy policy and clinician profile. A letter is filed under an operating entity, and a company may trade under names that appear nowhere in it, so the screen is run against the entity and the address rather than against the brand on the storefront. A name resemblance is never the test, because attaching one company's enforcement record to another is a worse error than missing a disclosure.
What the ledger records since
OrderlyMeds is recorded against criterion S8, enforcement status as PASS. The basis reads: FDA warning letter 728291, June 2026, names OrderlyMeds LLC and alleges misbranding; no FDA action has halted the business, and the seller still trades. The storefront was reachable and trading when the record was last read.
The index carries no close-out letter for it. When the index was read in September 2026 it held 3,677 letters and 417 of them carried a close-out letter, so the column is populated and an empty cell is a reading rather than a gap. A letter that has been neither closed out nor followed by an action is the ordinary state of a warning letter.
Why this is not a disqualification
A warning letter identifies a concern, requests a response, and states that failure to address the violations may result in legal action, including seizure and injunction. Those actions are what criterion S8 fails on. The letter is the notice that precedes them and it is not one of them, so this ledger records it in full, dates it, links it, and leaves the seller listed and linked exactly as a seller with no letter.
2 other letters in this ledger carry the same issue date: 728236, to Trinity HealthCare Supply, LLC dba altRx, 728279, to Eden Health International Inc. dba Eden.
Sources
- FDA warning letter 728291 to OrderlyMeds LLC dba OrderlyMeds, read in full
- FDA, About Warning and Close-Out Letters
- FDA warning letter index, and its close-out column
- The seller record this letter is disclosed on
The letter was fetched from fda.gov and read in full on the date in the meta line above, in a run where every letter this ledger discloses returned a document and a fabricated letter address returned nothing, by the same method. This page ranks nothing, recommends nothing, and carries no partner link.