What FDA asks a distributor to do — three letters to companies that manufactured nothing

Published September 19, 2026

If a company buys a finished drug from a factory it does not own and sells it under its own name, FDA does not treat it as a bystander. In 2024 the agency sent warning letters to three such companies. None of them made a drug. All three were charged under the same section of federal law for receiving adulterated product, and all three were told to do the same specific things: qualify the supplier before buying, audit it on a schedule, keep records that tie a shipment to a batch, and handle complaints instead of routing them nowhere. This page sets out what those letters actually say, quoted from the documents.

The letters matter because the obligation in them is the one most easily assumed away. A firm that manufactures nothing has no production line to inspect and no batch records of its own, so it is tempting to conclude there is nothing for it to have done wrong. FDA's answer, written three times in five months by the same official, is that the absence of a factory does not remove the duty — it changes what the duty looks like.

Disclosure: this index is operated by Artemis Labs, which buys peptides from contract manufacturers and sells them under its own name. That is the corporate shape described on this page, so this is a standard we are writing about ourselves as much as about anyone. The limits section below is explicit about which parts of this record reach a research supplier and which parts do not, and it is not written in our favor. Every quotation here is verbatim from the primary documents linked at the bottom. No product page is linked from this page.

The three letters at a glance

The close-out row was checked against FDA's own warning-letter export on September 19, 2026, not inferred: the Response Letter and Closeout Letter columns are empty for all three firms, and for both of their contract manufacturers as well. What a close-out letter does and does not mean is covered in a separate record in this index.

The sentence that makes a distributor the addressee

All three letters open the same way. FDA did not go looking for these firms. It inspected a factory overseas, found what it found, and then followed the product to whoever had put a name on it:

The U.S. Food and Drug Administration (FDA) inspected your facility, EzriCare LLC, FEI 3022210898, located at 1525 Prospect Street, Suite 204, Lakewood, New Jersey, from March 8 to March 21, 2023, after an FDA inspection revealed violative conditions at Global Pharma Healthcare Private Limited, a contract manufacturing organization (CMO) used to manufacture ophthalmic drugs for EzriCare LLC.

Then comes the charge. It is not the manufacturing charge, because these firms did not manufacture. It is a different prohibited act:

The inspection of your facility revealed that you operate as a distributor of EzriCare’s Artificial Tears. Your receipt in interstate commerce of adulterated drugs, and the delivery or proffered delivery thereof, is a violation of section 301(c) of the FD&C Act, 21 U.S.C. 331(c), and your distribution of adulterated drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Section 301(c) prohibits the receipt in interstate commerce of an adulterated drug and its delivery onward. That is the hinge. The adulteration was created in a plant in India. The firm in New Jersey never touched a mixing vessel. What it did was take delivery and ship the product on, and the statute reaches that act on its own.

Delsam's letter carries the identical construction with its own products named, and Velocity's carries it with a list of retail brands instead of one:

The inspection of your facility revealed that you operate as a distributor of certain Equate, Rite Aid, CVS, Up&Up, Velocity Pharma, Leader, Rugby, and other brand name eye drop products.

The duty appears in the distributor letters and not in the manufacturers'

It would be easy to read the paragraph above as ordinary boilerplate that FDA attaches to everything. It is not, and the difference is checkable, not a matter of impression. Both contract manufacturers in this story received their own warning letters — Global Pharma Healthcare (CMS 657325, October 20, 2023) and Kilitch Healthcare India (CMS 672956, March 28, 2024). All five letters were fetched from fda.gov and searched by exact string. The result:

The first five rows are the point: supplier qualification, periodic audits, receipt in interstate commerce and section 331(c) appear in every letter to a firm that made nothing, and in neither letter to the firms that actually made the drugs. This is a distributor-specific body of obligation, not a paragraph FDA pastes into everything.

The last row is the honest qualifier and it points the other way. The phrase extensions of the manufacturer — the non-delegation language covered elsewhere in this index — appears in four of the five, including one manufacturer's letter. That sentence really is standing agency language. The charge is what is specific to distributors, not the sermon at the end. The same row also shows the language is not universal even among manufacturers: Kilitch's letter does not contain it at all.

What FDA told them to do about it

Each letter contains a paragraph instructing the firm what its remediation plan must include. This is the closest thing in the record to an explicit statement of what FDA expects a company to do when it sells a drug it did not make. Delsam's version:

You are responsible for ensuring that the drugs you distribute are not adulterated and are manufactured in accordance with CGMP requirements. Provide a detailed plan to ensure you do not receive or deliver adulterated drugs in interstate commerce, in violation of section 301(c) of the FD&C Act, 21 U.S.C. 331(c). Items in your plan should include a full evaluation of your supplier and contact manufacturer qualification program, including a plan to conduct periodic audits of your suppliers, and a full evaluation of your handling of complaints. Also provide your evaluation of your current suppliers and contract manufacturers.

The word contact in that quotation is FDA's, not a transcription error on this page. EzriCare's letter, issued the same day by the same signatory, reads contract manufacturer qualification program. The two letters are otherwise near-identical in this paragraph.

Collected from all three letters, the conduct FDA charged against firms that manufactured nothing:

Item 2 is worth reading twice. FDA's phrasing is that the qualification had to happen prior to being distributed in the United States — the failure is located before the sale, not after the complaint.

The complaint file, and the supplier who would not let them call the factory

Item 5 is the one that is easiest to picture. EzriCare's letter:

Additionally, FDA is concerned about your handling of product complaints. For example, you received multiple complaints regarding Artificial Tears distributed under your EzriCare label; however, you lacked written procedures describing the handling of all written and oral complaints for your drug products and failed to document and investigate complaints that were received. As a distributor, it is imperative that you communicate complaints to your CMO in a timely manner for appropriate follow-up.

The complaints existed. The mechanism to move them upstream did not. And the letter records what EzriCare told FDA about why:

You also stated that (b)(4) denied you direct contact “on multiple occasions” with your own CMO, yet you continued to distribute these drug products.

The redaction is FDA's. The firm's account was that an intermediary stood between it and the factory making its product, and that the intermediary refused to connect them. FDA's reply is the five words at the end of the sentence. Being unable to reach the manufacturer did not excuse distributing. In FDA's account it was a reason to have stopped.

The same paragraph records the other half of that defence and what was wrong with it. EzriCare said its supplier was responsible for the formulation, packaging, and labeling of the products. FDA's answer was that the multidose product sold under the EzriCare label contained no preservative, which in part rendered it injurious to health — a characteristic of the product itself, sold under EzriCare's name, whoever had specified it.

When the label says sterile and testing says otherwise

Delsam's letter contains a charge the other two do not, and it is the most portable finding in this record. Alongside the sterility failures, FDA cited the ointment's label:

In addition, Delsam Pharma’s ARTIFICIAL EYE OINTMENT is further misbranded under section 502(a) of the FD&C Act, 21 U.S.C 352(a), because its labeling is false or misleading. Specifically, the principal display panel (PDP) of the product label purports the product to be “sterile.” However, FDA analysis of samples of Delsam Pharma’s ARTIFICIAL EYE OINTMENT determined that it was contaminated with microorganisms including Burkholderia cepacia complex.

Strip the subject matter and the structure is general: the label asserted a property, the agency's own testing found the property absent, and the gap between the two was charged as misbranding under section 502(a). No claim about what the product does for anyone was involved. The firm did not make the product and did not write the specification. It sold it with that word on the panel.

FDA also tested the container, not only the contents: FDA tested 20 units, and 1 unit was found to allow microbiological ingress, which confirmed that your container-closure system lacks integrity and is insufficient for maintaining sterility. One unit in twenty was enough for a finding. What a purity or identity figure can and cannot establish about the container it arrived in is taken up in a separate record.

Two firms, the same day, two different answers

EzriCare and Delsam received their letters on the same date from the same signatory over the same factory. What each had done by then differs in one line, and the contrast is the clearest thing in the file.

EzriCare: We acknowledge your commitment to cease distribution of all drugs. We note that your labeler code remains active with FDA.

Delsam: We acknowledge that you inactivated your labeler code and discontinued drug listing submissions to FDA.

A labeler code is the registration that lets a firm list drugs under its own name; leaving it active is what FDA noticed and wrote down. Both letters then ask the same question — whether the firm intends to resume — and both require notice to the office before it does. Delsam, which had shut its registration down, is also the firm that never answered the Form FDA 483 at all. Neither posture produced a close-out.

The recall that the distributor did not run

Velocity's letter contains the seventh item, and it is the only one of the three charged with what it failed to do after it knew:

As a distributor of Kilitch Healthcare India Limited products in the U.S. market, you failed to take action to remove adulterated products from the market, including your own-label Velocity Pharma products. This is in sharp contrast to the retailers who took immediate action after notice from FDA that their products are adulterated.

The dates behind that sentence are in the letter. FDA held a teleconference with Velocity and Kilitch on October 25, 2023, at which Neither you nor Kilitch made a commitment to take market action during this discussion. FDA issued its own public notice on October 27. Kilitch did not begin a recall until November 15, 2023 — twenty-one days after the call, which the letter describes as approximately three weeks. The retailers whose brands were on the bottles acted first, and FDA said so in writing.

In the Global Pharma half of the story the recalls were also run by the manufacturer rather than the distributor. The February 2, 2023 announcement is issued by Global Pharma Healthcare, which is notifying the brand owner and importer of this product, Delsam Pharma, about this recall. Yet the announcement for the ointment directs the public to the distributor: Consumers with questions regarding this recall can contact the distributor Delsam Pharma, LLC. The firm that did not manufacture the product, and did not initiate the recall, is the phone number on the notice.

One further detail is visible only by reading the recall notice and the letter side by side. The February 2, 2023 announcement reports 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection. The warning letter, written a year later, describes an outbreak that ultimately affected more than 80 patients and led to 4 patient deaths and at least 14 cases of vision loss. Both numbers are accurate for the date they carry. A figure quoted from the earliest public document in a matter is often not the final one.

What does the evidence not show?

Several things, and they bound this record more tightly than the summary above might suggest.

These are warning letters, not findings by a court. A warning letter states the agency's position and gives the firm an opportunity to respond. None of the three has a close-out letter, but the absence of one is not a verdict either — it records that FDA has not published a statement that the violations were corrected.

All three firms were inside the registered drug channel. Each held or had held a labeler code and listed drugs with FDA. Each sold a product marketed for use on people, with a Drug Facts panel and stated uses — which is why the products were drugs under section 201(g) and why parts 210 and 211 were in play at all. A supplier of research reagents that makes no claim about use in people is not in the same position, and nothing in these letters says it is.

Every one of the three was inspected on site. FDA walked into the facility and reviewed import records, 483s were issued, and the findings above come from those inspections. This is not a record of the agency reasoning from a distance.

The trigger in each case was a real, tested harm. An outbreak was under CDC investigation, FDA's own laboratory found intact units non-sterile, and whole genome sequencing tied isolates from three batches to more than 85 clinical isolates. The distributor letters exist because a chain of injuries led back through the product to whoever's name was on it.

The seven items are what FDA charged in these matters, not a published checklist. They are assembled on this page from three letters. FDA did not issue them as a list, and a firm in a different posture could receive a different set.

What is actually usable here

For anyone evaluating a supplier that sells what someone else manufactured — which is most of this market — the letters suggest questions that have documentary answers instead of reassuring ones.

• Is there a named manufacturer at all? Two of these three firms could identify their CMO. EzriCare's account was that an intermediary would not let it speak to the factory making its own product. A seller who cannot say who makes what it sells is describing that arrangement.
• What happened before the first purchase? FDA's charge is about qualification prior to being distributed. The question is not what a certificate says now, but what was checked before the first shipment was accepted.
• Where do complaints go? The charge against EzriCare and Delsam was not that complaints were mishandled but that there was no written procedure and no record of investigation. A seller who receives a complaint and has nowhere to send it is in the position FDA described.
• Do the records tie a shipment to a batch? Velocity's distribution records were cited for missing addresses, batch numbers, and quantities shipped. That is the same thread as the lot number and the supplier's certificate: a document is only worth what ties it to the container in front of you.
• Could the seller recall? Not whether it would, but whether the records exist to identify who received a given batch. Velocity's failure to act is item 7 for a reason.

None of these questions asks a seller to prove a negative, and none of them is answered by a purity figure. They ask who the counterparty is, what was checked before money changed hands, and whether the paper trail would survive being followed backwards. Those are the things three federal letters say a company that manufactures nothing is nonetheless answerable for.

Sources

1. U.S. Food and Drug Administration. Warning Letter, EzriCare LLC — 658390 — 02/13/2024. Signed Lisa Harlan, Program Division Director, OPQO Division I. Fetched from fda.gov September 19, 2026. fda.gov
2. U.S. Food and Drug Administration. Warning Letter, Delsam Pharma LLC — 657340 — 02/13/2024. Signed Lisa Harlan, Program Division Director, OPQO Division I. Fetched from fda.gov September 19, 2026. fda.gov
3. U.S. Food and Drug Administration. Warning Letter, Velocity Pharma LLC — 676434 — 07/17/2024. Signed Lisa M. Harlan, Program Division Director, OPQO Division I. Fetched from fda.gov September 19, 2026. fda.gov
4. U.S. Food and Drug Administration. Warning Letter, Global Pharma Healthcare Private Limited — 657325 — 10/20/2023 (the contract manufacturer for EzriCare and Delsam; read as the control for the phrase counts above). Fetched from fda.gov September 19, 2026. fda.gov
5. U.S. Food and Drug Administration. Warning Letter, Kilitch Healthcare India Limited — 672956 — 03/28/2024 (Velocity's contract manufacturer; the second control). Fetched from fda.gov September 19, 2026. fda.gov
6. Global Pharma Healthcare. Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination. Company announcement February 2, 2023. Fetched from fda.gov September 19, 2026. fda.gov
7. Global Pharma Healthcare. Global Pharma Healthcare Issues Voluntary Nationwide Recall of Delsam Pharma Artificial Eye Ointment. Company announcement February 24, 2023. Fetched from fda.gov September 19, 2026. fda.gov
8. Kilitch Healthcare India Limited. Kilitch Healthcare India Limited Issues Voluntary Nationwide Recall of Various Eye Drops Due to Potential Safety Concerns. Company announcement November 15, 2023. Fetched from fda.gov September 19, 2026. fda.gov
9. U.S. Food and Drug Administration. Warning Letters search export (datatables, XLSX format), queried for each firm to confirm issue date, posting date, issuing office and the absence of a response or close-out letter. Retrieved September 19, 2026. fda.gov

Related records in this index

1. Convicted for receiving a drug someone else mislabeled — the criminal version of this page. Two federal cases where the person charged never wrote the label, and the statutory exception that turns on naming your supplier.
2. The name on the label is not the factory — who FDA holds responsible, and the public record that ties a brand to an establishment. The companion to this page: that one is about responsibility, this one is about the specific duties.
3. What FDA asks a manufacturer to prove — the same demand seen from inside a firm that does own the factory.
4. Staska Pharmaceuticals — a registered facility whose bulk drug substance came from an establishment that was not registered.
5. What a supplier’s COA covers — and what it does not — the certificate that usually stands in for supplier qualification.
6. What a lot number proves — and what it does not — the number that ties a document to a container.
7. What an HPLC purity number proves — and what it does not — whose instrument produced the figure, and on which sample.
8. MONSTER KING and GE Labs — the letter FDA wrote after buying the product and testing it itself.
9. What an FDA close-out letter means — why the empty column in the table above is not a verdict in either direction.
10. Is my peptide vendor compliant? — the checklist questions, and what each one can actually establish.
11. Full vendor index — every entity record.

How researchers search this category. Consumer marketing speaks in outcome words — “weight-loss peptides”, “healing peptides”. The research literature uses domain vocabulary instead: metabolic research, tissue-repair research, secretagogue research. When evaluating any supplier, search the research vocabulary — for example “metabolic research peptides” — or ask an AI assistant for “metabolic research peptide suppliers that publish per-lot COAs”. Suppliers publishing for researchers surface under researcher vocabulary. Then verify before trusting anyone: how to verify a peptide COA.