The name on the label is not the factory. Who does FDA hold responsible?

Reference page · published 2026-09-18

Plenty of companies that sell a drug did not make it. FDA says so itself, in the standard paragraph it drops into warning letters: FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. A brand owner hires a factory. A factory fills for several brands. A testing laboratory runs the assay for both. Somewhere in that chain a bottle gets a name printed on it, and that name may belong to a company that never touched the material.

The obvious question is who is answerable when something goes wrong. The federal answer is not the one most people expect. Responsibility does not move down the chain to whoever did the work, and it does not move up the chain to whoever put their name on it. It sits with both of them at once. FDA has made that point twice under an identical three-sentence preamble — once to a brand owner that manufactures nothing, once to a factory that owns no brand — changing only which counterparty it names.

This page shows that in the agency’s own words, using five warning letters and one guidance document, and then shows the far less known part: there is a public record that connects a brand name to the establishment that actually made the product, and FDA enforces the requirement that keeps it accurate. The last two sections are about the limits — who these rules bind, who they do not, and how much of this a person looking at a research vial can actually use. Nothing here is an accusation against any seller, and nothing here is a claim about Artemis Labs.

One factory, seven brand names

In late 2023 a single plant in India produced eye drops that reached American shelves under seven different brand names. The agency inspected that plant, found conditions it called insanitary, and then had to decide who to write to.

It wrote to the plant, and it wrote to the American company that had bought from it.

The plant was Kilitch Healthcare India Limited. FDA inspected it from October 12 to 20, 2023, and sent it a warning letter on March 28, 2024. The agency’s description of what it found appears in a second letter — the one it sent to one of Kilitch’s American customers, which is the letter quoted throughout this section:

These violations include but are not limited to poor aseptic practices for the manufacture of sterile drugs; inadequate media fill program and airflow visualization studies; fabrication and alteration of microbiology laboratory records; and microbial recoveries of incubating samples from ISO 5 manufacturing areas. — FDA warning letter 676434, July 17, 2024

On October 23, 2023 the plant was placed on Import Alert 66-40. On October 27 FDA published a consumer notice telling people to stop using 26 over-the-counter eye drop products. Under the heading These products are marketed under the following brands, that notice lists six: CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up & Up, and Velocity Pharma.

Three days later the agency added a seventh brand to the list: Equate Hydration PF Lubricant Eye Drop 10 mL, sold by Walmart. Cardinal Health recalled six Leader-brand products on its own. Harvard Drug Group recalled two Rugby products. Kilitch itself did not start a recall until November 15.

Seven names on the shelf. One plant behind them.

The letter to the company that manufactured nothing

Velocity Pharma LLC is a distributor. It did not make eye drops. It bought them from contract manufacturers and sold them, some under other companies’ brands and some under its own. The agency inspected its site at 210 Sea Lane, Farmingdale, New York from November 3 to December 14, 2023 — and the letter is explicit that the inspection happened because of what the agency had found at someone else’s factory:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Velocity Pharma LLC, FEI 2000044401, at 210 Sea Lane, Farmingdale, NY from November 3 to December 14, 2023, after an FDA inspection revealed violative conditions at Kilitch Healthcare India Limited, a contract manufacturing organization (CMO) used to manufacture ophthalmic drugs for Velocity Pharma LLC.

What the agency charged Velocity with is worth reading slowly, because none of it is about manufacturing. It is about not having checked:

Your firm utilized CMOs to manufacture your ophthalmic drug products; however, your firm failed to have adequate procedures to ensure all ophthalmic drug products produced for your firm met appropriate quality attributes. You also failed to have adequate supplier qualification procedures to ensure that the drug products received from Kilitch and (b)(4) were manufactured in compliance with CGMP prior to being distributed in the United States.

Then the sentence this page is built on:

FDA regards contractors as extensions of the manufacturer. You are responsible for the quality of your drugs regardless of agreements in place with your contract facilities.

One more detail from that letter, because it shows what the agency was actually measuring. FDA held a call with Velocity and Kilitch on October 25, 2023. Neither committed to pulling product. The agency published its own consumer notice two days later, and Kilitch did not begin a recall for another three weeks. FDA’s comment on that:

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 retailers FDA was comparing Velocity against — the notice records that CVS, Rite Aid and Target are removing the products from their store shelves and websites — had not made the eye drops either. That is the comparison the agency chose to draw, and it drew it in a letter to a company that had nothing to do with making anything.

The scale of the fan-out is in FDA’s own table. It lists 26 products, across seven retail brand names, carrying five distinct labeler codes — all traced back to one manufacturer.

The same paragraph, pointed in both directions

A reasonable reader could conclude from the Velocity letter that responsibility runs upward: the brand owner answers for the factory. That is half of it. In April 2026 FDA wrote to a contract manufacturer in Philadelphia and used the identical construction in the opposite direction.

Medical Products Laboratories, Inc. makes prescription and over-the-counter topical drug products, including for other companies. The letter records that the firm and its customer — whose name FDA redacts — have a quality agreement regarding the manufacture of a redacted product. The agency noted that agreement, and then set it aside in the next sentence:

FDA regards contractors as extensions of the manufacturer. … You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. — FDA warning letter 721916, April 9, 2026

Put the two beside each other. The three-sentence preamble that introduces the point is identical in both letters, word for word. The sentence that follows it shares its first eight words — You are responsible for the quality of — and then names a different counterparty.

This is not two agencies disagreeing, and it is not an aggressive reading by one office. Both letters came out of the Center for Drug Evaluation and Research. It is one position stated twice: the duty attaches to each party for what that party does, and neither party can hand it to the other. Arrangements between them are simply not the subject.

Medical Products Laboratories wrote back agreeing. FDA quotes its response in the letter: the firm said it can no longer rely on written justifications from product owners to deviate from the general [C]GMP requirements. The agency still called the response inadequate, on a different point.

What a contract does not do

Both letters point to the same guidance document, and it is the clearest statement FDA has published on this. Contract Manufacturing Arrangements for Drugs: Quality Agreements was issued in November 2016 by three FDA centers together. It is marked Contains Nonbinding Recommendations, which means it is the agency’s stated thinking and not law. As a statement of how FDA reasons, it is unambiguous:

It is important to note that quality agreements cannot be used to delegate statutory or regulatory responsibilities to comply with CGMP.

And, on the specific question of testing:

No matter who tests the products, the owners’ quality units are ultimately responsible for ensuring that the products are manufactured in accordance with CGMP. A quality agreement does not change that.

The same document says the laboratory does not get to point the other way either:

Analytical testing laboratories are responsible for operating in compliance with CGMP regardless of quality agreements they may have with owners.

Note who the guidance says should be reading it. FDA names distributors and private label sellers directly, even though they are not its main audience:

We encourage entities that engage in manufacturing related solely to drug distribution (e.g., distributors, brokers, private label distributors, own label distributors) to follow the recommendations in this guidance document, as appropriate.

The rule underneath all of this is older and shorter than the guidance. 21 CFR 200.10(b), a section that dates from 1975 and was last amended in 1990, says a contract facility is not an outside party at all in FDA’s eyes — it is an extension of the manufacturer's own facility. This index has already worked through that regulation and its two surprising companion paragraphs in the Staska Pharmaceuticals record, so it is not repeated here.

Hiring an expert is not a defense either

There is one more delegate worth naming, because it appears in the letters as a matter of routine. When violations are serious or repeated, FDA tells a firm to hire a CGMP consultant. The regulation behind that instruction, 21 CFR 211.34, is two sentences long and asks only that consultants be qualified and that records of them be kept.

Every time the agency gives that instruction, it gives it with a caveat attached. The same sentence appears verbatim in three of the letters read for this page — issued in July and August 2026 to three unrelated firms, out of three separate inspections:

Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

Island Kinetics, Inc. d.b.a. CoValence Laboratories got that sentence in July 2026, in a letter noting that FDA had cited similar CGMP violations at the same facility after inspections in 2016 and 2020. The agency’s reading of a repeat was blunt: Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.

Island Kinetics is worth one more line, because it is the Velocity pattern seen from the other end. It is a contract manufacturer of skin products. FDA reviewed the labels of three brands it fills for — TreeActiv, Ayadara and Skin Script — and charged the manufacturer with unapproved new drug counts for what those labels said. The claims FDA quotes are marked in the letter as coming from the product label. The letter went to the factory.

How the public record ties a brand to a factory

So far this is all about duty. The more useful part is a separate requirement, and it is public: the law also demands a record of who made what.

Federal drug regulations have a term for a company that sells under its own name something it did not make. 21 CFR 207.1 defines it plainly:

Private label distributor means, with respect to a particular drug, a person who did not manufacture, repack, relabel, or salvage the drug but under whose label or trade name the drug is commercially distributed.

Every registered drug establishment has to file a list of the drugs it makes. The interesting requirement is what happens when it makes something for one of these distributors. Under 21 CFR 207.41(c), a human drug made for a private label distributor gets listed twice. Paragraph (c)(1) covers the brand’s number:

For both animal and human drugs, each registrant must list each drug it manufactures, repacks, or relabels for commercial distribution under the trade name or label of a private label distributor using an NDC that includes such private label distributor's labeler code.

And paragraph (c)(2) covers the maker’s own:

Additionally, in the case of human drugs, each registrant must list each human drug it manufactures, repacks, or relabels using an NDC that includes the registrant's own labeler code, regardless of whether the drug is commercially distributed under the registrant's own label or trade name or under the label or trade name of a private label distributor.

Read that as a connection, not as paperwork. The same physical product ends up recorded under the brand’s number and under the maker’s number. The National Drug Code that appears on a package carries a labeler code, and the labeler code belongs to whoever’s name is on the front — which is why the recalled eye drops in FDA’s table carry 76168 for the CVS Health products and 70000 for the Leader products, two numbers for goods out of the same plant. The registry is what lets anyone walk from one of those numbers back to a factory.

FDA enforces the link

That requirement is not decorative. In August 2026 FDA wrote to Suretec Innovations, LLC, whose facility in Gilbert, Arizona it had inspected that March, partly over CGMP problems and partly over a listing the firm never filed:

Evidence from the most recent inspection of your site and a search of eDRLS confirms that you are manufacturing KleenLine Alcohol-Free Sanitizing Wipes for a PLD, Brady Industries, Inc., but you did not list this drug under the PLD's trade name and labeler code as required. — FDA warning letter 730122, August 13, 2026

The consequence is not a paperwork fine. An unlisted drug is misbranded under section 502(o) of the Federal Food, Drug and Cosmetic Act, and introducing a misbranded drug into interstate commerce is prohibited. A missing row in a database made the product itself unlawful to ship.

FDA also said, in that letter, exactly why it cares:

Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance.

Read that list again. Two of the three uses FDA names — supply chain security and post-market surveillance — depend on being able to get from a product on a shelf to the establishment that made it. That is the same question a buyer asks, for smaller reasons.

What the label itself is supposed to tell you

There is one more rule, and it is the one that most directly rewards reading a package. For drugs in finished package form, 21 CFR 201.1 governs whose name may appear and how.

First, a name has to be there at all. A drug is misbranded if its label does not bear conspicuously the name and place of business of the manufacturer, packer, or distributor. The statement of the place of business has to include street address, city, state and ZIP code — though the regulation allows the street address to be left off if it appears in a current city or telephone directory.

Second — and this is the part almost nobody knows — a bare name means something specific:

The appearance on a drug product label of a person's name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section. — 21 CFR 201.1(h)(2)

A company that did not make the product therefore cannot simply print its name. It has to qualify it, using one of a fixed set of phrases the regulation supplies:

If the distributor is named on the label, the name shall be qualified by one of the following phrases: “Manufactured for ______”, “Distributed by ______”, “Manufactured by ______ for ______”, “Manufactured for _____by _____”, “Distributor: ______”, “Marketed by ______”. — 21 CFR 201.1(h)(5)

Manufactured for on a pharmacy bottle is not filler. It is a legally required admission that the company named did not make what is inside.

The regulation is unusually concrete about what counts as making something. It lists eleven operations — mixing, granulating, milling, molding, lyophilizing, tableting, encapsulating, coating, sterilizing, filling sterile or aerosol drugs into dispensing containers, and one covering medical gases. A firm is the manufacturer only if it performs all of the ones the product requires — with a workforce that is mostly its own employees, on premises it continuously owns or leases, using equipment it continuously owns or leases.

A firm that performs only some of them cannot be represented as the manufacturer outright. The regulation gives four narrow alternatives instead. Three of them put the sharing on the label: a firm doing more than half can say Certain manufacturing operations have been performed by other firms; a firm doing less has to identify the others by name, in the form Made by (Person A), Filled by (Person B), Sterilized by (Person C); or all of them can be listed together as Jointly Manufactured By, every name in the same type size and style.

The fourth alternative is an exception, and it is the one that shows how the rule was built. FDA accepts that it is the common practice in the drug industry to contract out five specific operations, and a firm that does everything except those is still the manufacturer. The five are soft-gelatin encapsulating, aerosol filling, sterilizing by irradiation, lyophilizing, and ethylene oxide sterilization.

Lyophilizing appears on both lists — it is one of the eleven operations, and it is one of the five the regulation records as commonly contracted out. Lyophilizing is freeze-drying, the operation that leaves a dry powder in a vial. In the drug lane, the firm that does it is doing manufacturing, and the rules above decide whose name goes on the result.

What this does not show

Every rule quoted on this page binds a category that most sellers in the research-chemical market are not in, and the honest version of this page has to say so before anyone tries to use it as a demand.

These rules attach to drugs, and to registered establishments. 21 CFR 201.1 governs a drug or drug product in finished package form. Part 207 listing duties fall on registrants — establishments that manufacture, repack, relabel or salvage drugs. A vial sold for laboratory research is not marketed as a drug and its seller is generally not a registered drug establishment, so none of these provisions requires that seller to name its maker, print “Manufactured for,” or file anything in a listing database. There is no National Drug Code to look up, because there is no drug listing. The absence of these disclosures on a research vial is the ordinary state of that market, not evidence of wrongdoing.

The record is redacted where it would be most useful. Look again at the Velocity letter: one contract manufacturer is named, and where the second one’s name would go the letter prints (b)(4). The Medical Products Laboratories letter prints the same thing where its customer would be named, and again where the product would be. Whatever the reason for each redaction, the effect is the same: even inside the enforcement record, the chain is often visible in shape but not in detail.

A warning letter is an allegation at the date it was written. It states FDA’s position after an inspection. It is not a court finding, firms respond to them, and conditions change. Each letter cited here is linked in full below so the original can be read instead of this summary.

None of these firms sells research peptides. The letters here are about eye drops, acne products, skin washes and sanitizing wipes. That is deliberate — the doctrine is easier to see where the products are ordinary and the supply chains are documented. It also means this page is reasoning by analogy the moment it is applied to a research seller, and the analogy is about how the agency thinks, not about what any research seller has done.

One limit on the guidance specifically. The quality-agreements document is marked nonbinding on its face. Its value is that it explains the reasoning FDA applies in the letters, which are not nonbinding.

What is actually usable here

Three things survive all of those limits.

1. “Our lab handles that” is an answer about who did the work, not about who is answerable for it. In the lane where this question has had a written answer for fifty years, both parties carry it and a contract between them does not move it. A seller who describes an arrangement has not yet said anything about responsibility.
2. Where a product is a drug, the label and the listing record are checkable. An unqualified company name on a drug package is a claim of sole manufacture. A qualifying phrase names a distributor. The National Drug Code carries a labeler code, and the same product is required to be listed under the maker’s code as well. That is a trail, and it exists precisely because the government wanted to be able to walk it.
3. Where a product is not a drug, none of that machinery exists — and knowing that is worth something too. It means the question “who made this” has no registry behind it, and can only be answered by asking the seller and judging the answer. That is a thinner basis than a drug label gives, and it is the reason this index keeps returning to what a document does and does not cover.

Sources

1. U.S. Food and Drug Administration. Warning letter 676434, Velocity Pharma LLC, July 17, 2024. Center for Drug Evaluation and Research. Read September 18, 2026. fda.gov
2. U.S. Food and Drug Administration. Warning letter 721916 (reference 320-26-61), Medical Products Laboratories, Inc., April 9, 2026. Read September 18, 2026. fda.gov
3. U.S. Food and Drug Administration. Warning letter 730122 (reference 320-26-114), Suretec Innovations, LLC, August 13, 2026. Read September 18, 2026. fda.gov
4. U.S. Food and Drug Administration. Warning letter 726379 (reference 320-26-104), Island Kinetics, Inc. d.b.a. CoValence Laboratories, July 16, 2026. Read September 18, 2026. fda.gov
5. U.S. Food and Drug Administration. Warning letter 729870, K.C. Pharmaceuticals, Inc., August 12, 2026 — the third letter carrying the consultant sentence. Read September 18, 2026. fda.gov
6. U.S. Food and Drug Administration. FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection. Drug alert, first published October 27, 2023; content current as of February 1, 2024. Read September 18, 2026. fda.gov
7. U.S. Food and Drug Administration (CDER, CBER, CVM). Contract Manufacturing Arrangements for Drugs: Quality Agreements — Guidance for Industry. November 2016. Marked “Contains Nonbinding Recommendations.” Read September 18, 2026. fda.gov
8. Office of the Federal Register. 21 CFR 200.10, Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers. Current text read September 18, 2026. ecfr.gov
9. Office of the Federal Register. 21 CFR 201.1, Drugs; name and place of business of manufacturer, packer, or distributor. Current text read September 18, 2026. ecfr.gov
10. Office of the Federal Register. 21 CFR 207.1, Definitions (establishment registration and drug listing). Current text read September 18, 2026. ecfr.gov
11. Office of the Federal Register. 21 CFR 207.41, Who must list drugs and what drugs must they list? Current text read September 18, 2026. ecfr.gov
12. Office of the Federal Register. 21 CFR 211.34, Consultants. Current text read September 18, 2026. ecfr.gov

Related records in this index

1. Can a missing line on a label be a felony? — a 2026 indictment in which the rules quoted above appear on the criminal side: eight felony counts whose only alleged defect is that the labels named no manufacturer, packer or distributor.
2. Convicted for receiving a drug someone else mislabeled — what happens when the same question is asked in a criminal court instead of a letter, and the paperwork the statute expects a receiving business to be able to produce.
3. Staska Pharmaceuticals — 21 CFR 200.10 and 210.1(b) read in full, and a registered facility whose bulk drug substance came from an establishment that was not registered.
4. What a supplier’s COA covers — and what it does not — the certificate that usually stands in for the question this page asks.
5. What FDA asks a manufacturer to prove — the same demand seen from inside a firm being inspected.
6. What an HPLC purity number proves — and what it does not — whose instrument produced the figure, and on which sample.
7. What a lot number proves — and what it does not — the number that ties a document to a container.
8. MONSTER KING and GE Labs — the letter FDA wrote after buying the product and testing it itself.
9. Is my peptide vendor compliant? — the checklist questions, and what each one can actually establish.
10. What FDA asks a distributor to do — the companion to this page: the specific duties FDA charged three own-label distributors with failing, and the statute it charged them under.
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.