What does an FDA consent decree require? We read one — 18 pages, no end date, and counsel signed it before the lawsuit was filed

Reference page · published 2026-10-08

Short answer: a consent decree is not the end of a court fight. It is a settlement that arrives with the lawsuit, and it hands the FDA a standing set of powers over the company that the FDA did not have before. In the four cases we read, the United States filed a civil complaint and a federal court entered a permanent injunction between 2 and 33 days later. Nobody was charged with a crime. Nothing was proven. In the one decree we could obtain and read in full, the company agreed to stop making drugs unless and until it had hired an independent expert at its own expense, destroyed its stock under government supervision, recalled product it had already shipped, and received a letter from the FDA saying it appeared to be in compliance — and the decree is explicit that the FDA saying nothing does not count.

This matters here for a plain reason. This index tracks what happens to companies that sell research compounds, and it has a lot of pages about criminal cases and warning letters. The warning letters themselves close with a standard warning about what comes next — the one we read in full for this page says the company risks seizure and/or injunction — and until now this index had no page showing what the injunction half actually looks like when it lands. It is the ending that leaves a company standing and supervised instead of prosecuted, and it is the one almost nobody writes about.

The four cases, and how fast they ended

We searched the Justice Department's press archive for the verb a headline writer uses when a court has finished acting — enjoins — and read every release it returned. That search returns 55 releases in total, and the archive reports that total itself, so this is a count, not a guess. Thirty of the 55 are tax cases — return preparers, payroll liabilities, disgorgement — which is worth knowing before anyone tries the same search. Thirteen distinct releases are Food, Drug, and Cosmetic Act cases, spread across food, pet food, devices, dietary supplements, animal drugs and human drugs, with one release duplicated in the archive. Four of the thirteen are human-drug cases, and those four are the ones below.

The filing dates above are read from the court dockets. Each one is also stated in the press release that announced it, and in all four cases the two agree, so no filing date here rests on a single source.

The dates in the third column need more care, because a docket’s closing date and the date an order is entered are not always the same day. For two of the four we have a second source and they match. The Pharmasol docket closes on December 13, 2023, and the decree itself carries an electronic court stamp reading Filed 12/13/23. The Smart Women’s Choice docket closes on November 14, 2023, and the release says a federal court acted on Nov. 14. For the other two we use the date the release says the court acted, and we flag it, because the Edge Pharma docket was not closed until November 2023 — seventeen months after its injunction was announced.

The first row is the one worth sitting with. In the Morton Grove case the United States filed its complaint on a Wednesday and the court entered a permanent injunction on the Friday. That is not the shape of a contested case, and the next section shows directly, in the one file we could read, what the gap is actually made of.

Defense counsel signed the decree before the lawsuit was filed

We can show this for one case because the Justice Department attached the decree to its press release. On the signature page, defense counsel for the company signed with a digital stamp that records its own date: November 2023. The complaint was filed on November 17, 2023. The day digit in the stamp is crossed by co-counsel’s ink signature; read at 600 dots per inch it is an 08 or an 09, and we are not going to pretend to more precision than the scan supports. Either reading puts the signature eight or nine days before the United States went to court.

So the order of events is not the one most people would assume. The negotiation happens first, and the complaint and the settled decree reach the court together. In Pharmasol the whole visible proceeding ran 26 days, the docket closed the day the decree was entered, and the decree itself records that the company consented to entry of this Decree without contest and before any testimony has been taken.

The decree is published as a picture, not as text

Before anything in it can be quoted, one mechanical fact has to be stated, because it affects anyone who tries to check this themselves. The published PDF contains no readable text. It is 18 pages and 2,189,113 bytes, and the only machine-readable characters in the entire file are the court’s own header stamp on each page — Case 1:23-cv-12801-AK Document 13 Filed 12/13/23 Page 1 of 18 and its seventeen siblings. Strip those eighteen stamps and zero characters remain. A text extractor run over the file returns the stamps and nothing else.

This means you cannot search the document, you cannot copy a sentence out of it, and a search engine indexing it learns nothing but those stamps. Everything quoted on this page was read off the rendered page images, and every passage we quote was then read a second time from an independently rendered, higher-resolution crop before it was used here. We mention it partly as disclosure and partly because it is the same problem this index documented in a different form when we checked whether a court filing’s text and its printed page agree. A government document being public and a government document being checkable are two different things.

What the company had to do before it could sell again

The decree bars the company and its president from making, processing, packing, labeling, holding or distributing any drug at their facilities — and then lists the conditions. The operative words are unless and until, and what follows them is the real content of the order.

• Hire an independent expert, and pay for them. The company must retain, at its own expense, a CGMP Expert who is without any personal or financial ties (including, but not limited to, prior employment by Defendants) to the company or the family that runs it. The company must tell the FDA who that person is, and must follow the CGMP Expert’s guidance for remediation.
• That expert inspects, and reports to the government. The expert must inspect the facility and certify in writing to FDA whether the operation complies. The report has a required contents list, and the items on it read like a point-by-point answer to the complaint: whether the company investigated its own complaints and equipment-cleaning failures, whether its quality unit has written procedures and follows them, whether it closes complaints classified as critical and major in a timely manner, and whether it cleans its equipment.
• Recall what has already shipped. The company had to recall adulterated prescription drugs still within their expiry date going back to a fixed date almost two years before the decree — February 10, 2022.
• Destroy what is on the shelf, under supervision, within 30 days. And Defendants shall bear the costs of destruction and the costs of FDA’s supervision.
• Wait for a letter, and do not read anything into silence. The last condition is that the FDA notifies Defendants in writing that they appear to be in compliance. The decree then adds the sentence that gives the whole structure its shape: In no circumstance shall FDA’s silence be construed as a substitute for written notification.

There is a clock on the government’s side of that, but it is not a deadline to approve. The FDA has 45 days to respond to the expert’s report by concurring or explaining why it does not concur, and 30 days to respond to each revision. The decree says the cycle shall be repeated until Defendants receive written notification of concurrence from FDA. There is no number of rounds after which the company wins by default.

Then five years of audits, at the company’s expense

Getting the letter is not the end of it. After the FDA writes, the company must retain an auditor meeting the same independence criteria, who must conduct an audit of Defendants’ Facilities no less frequently than once every six (6) months for a period of no less than five (5) years. The audit reports go contemporaneously to Defendants and FDA — the company does not see them first — and observations have to be answered in 15 days and corrected in 15 days.

The bill is itemized in the decree. The company reimburses the FDA for inspections, investigations, supervision, analyses and reviews, at rates the document prints in full: $110.59 per hour per representative for inspection and investigative work, $132.56 per hour for analytical or review work, and $0.655 per mile plus tolls for driving. The decree adds that if the government’s standard rates change, these rates shall be increased or decreased without further order of the Court.

And a copy of the decree has to be posted in a common area of the company’s own facilities, and kept posted for as long as the Decree remains in effect.

After it is signed, the FDA can act by letter

This is the part that is hardest to see from the outside, and it is the reason a consent decree is a different animal from a warning letter. Once it is entered, the FDA does not need to go back to court to make the company stop. If the agency decides more corrective action is needed, it may, as and when it deems necessary, notify Defendants in writing of the noncompliance and order Defendants to take appropriate corrective action — and the listed options include ordering the company to Cease manufacturing, processing, packing, labeling, holding, and/or distributing any or all drugs, to Recall, at Defendants’ expense, to Destroy, at Defendants’ expense, to Issue a safety alert, and to Take any other corrective actions as FDA, in its discretion, deems necessary.

The company can disagree, in writing, within ten business days. The FDA then reviews its own order and may affirm, modify or withdraw it, and its written affirmation shall constitute final agency action. If the FDA affirms, the company must immediately implement the order and may then ask the court — while still implementing it. And if the agency’s order states that the matter raises a significant public health concern, even that ten-day exchange does not apply: the company must immediately and fully comply and argue afterwards.

When the court does review, the terms are set in advance. The decree says Defendants shall abide by the decisions of FDA, and FDA’s decisions shall be final, that review runs under the arbitrary and capricious standard, that it is based exclusively on the written record before FDA at the time the decision was made, and — in eight words — No discovery shall be taken by either party.

Breaking any of it has a price written into the document: $5,000 in liquidated damages for each day a violation continues, a further $5,000 for each violation, and on top of both a further additional sum equal to the retail value of drugs handled in violation of the Act, the regulations or the decree.

The individual defendant is a seat, not a person

In three of the four cases an owner or officer is a named defendant alongside the company: a CEO, a president, and two owners described as operators. The fourth, Morton Grove, names no individual at all — not in the release, not in the docket caption — and it is the largest manufacturer of the four, so the pattern is real but it is not a rule. The Pharmasol decree shows what being that named individual means over time, and it is not what we expected.

The named individual can get out. If he ceases to be affiliated with the company in any capacity (e.g., as owner, director, officer, employee, or consultant) and gives the United States satisfactory evidence of it, he carries no liability for what the company does afterwards. But the company cannot be left without one. Within 30 days of his departure, the company shall designate an individual of similar position and responsibilities to be named as an individual Defendant, must tell the FDA who it is, and must petition the Court to add this individual to the Decree — and This new individually-named Defendant shall be bound by the Decree in the same manner as the originally named individual Defendant.

The matching provision covers the company itself. It must notify the FDA at least 15 days before any change in ownership, name, or character of their business, and the list of what counts is deliberately long: an incorporation, reorganization, creation of a subsidiary, relocation, dissolution, bankruptcy, assignment, sale, or any other change in the structure or identity of the corporate Defendants. A prospective buyer has to be given a copy of the decree 30 days before any sale.

There is no expiry clause

We looked for one. The decree runs to 24 numbered paragraphs, and the last of them is not a sunset — it is the opposite: This Court retains jurisdiction over this action and the parties thereto for the purpose of enforcing and modifying this Decree, and for granting any further relief that turns out to be needed. Then SO ORDERED, this 13th day of December, 2023, signed by United States District Judge Angel Kelley. No paragraph anywhere in the document sets a date on which it ends, and no paragraph describes how the company might ask for it to end. The five-year audit requirement is a floor on one obligation, not a term for the order.

What starts it: a letter, and then a long wait

In three of the four cases, the government’s complaint recites that the FDA had warned the company before. Morton Grove is described as having been inspected five times — in 2011, 2014, 2016, 2019, and 2021 — and sent several warnings, including a warning letter to the company in 2017. Pharmasol was inspected in 2018, 2021 and 2022 and sent a warning letter in 2019, and the complaint alleged it had taken 533 customer complaints about product defects in a 12-month period without establishing a complaint procedure. The Vermont compounding pharmacy’s release names inspections between 2014 and 2021 and no warning letter at all — which is why we say three of four and not four of four.

The fourth case is the one where the whole arc is readable end to end, because the warning letter is still published. On May 19, 2021, the FDA sent a warning letter (number 614359) to the company over a cream sold through a website. The letter is built almost entirely out of the company’s own marketing: it quotes the website, the company’s own science page, the order page, its Facebook page and its Instagram posts by date, including a customer’s own words quoted back from the order page. The claim the Justice Department would later repeat — 99.8% effective — is quoted in the 2021 letter from the company’s Facebook “About” sidebar. The letter closes with the standard sentence: failure to address the matter may result in legal action including, without limitation, seizure and/or injunction.

The complaint was filed 876 days later — almost two and a half years. According to the complaint as the Justice Department describes it, the company continued to make the same unproven claims about the product after receiving the warning letter and took no corrective action. The decree entered 33 days after that permanently enjoins the company and requires them to comply with federal drug safety regulations before selling any drugs.

One detail in that case is worth recording because it is the sort of thing a reader checking a company would trip over. The person the warning letter is addressed to and the person the United States later sued are not the same person. The 2021 letter is addressed to a named chief executive; the 2023 release names a different individual as the company’s CEO and second defendant. Neither document mentions the other name. The letter also gives a California address for the company, while the case was filed in Arizona and the Justice Department calls it an Arizona company. We record both discrepancies and draw nothing from either: two years separate the documents, and companies and officers change in two years.

The mechanism that made the claim false

The Arizona case turns on something subtler than a lie, and it is the part of this record that reaches furthest. Nobody produced evidence that the product did not work. What the complaint alleges, in the Justice Department’s words, is that the FDA found no published, adequate and well-controlled clinical investigations or any other scientific literature behind the claims the company was making for the product.

The absence of supporting literature is the case. A company made a specific numerical claim; the government went looking for published work behind it and found none; that was enough to plead. For an index built on citations this cuts both ways and we would rather say so than not: dense citation is not decoration, and a claim with nothing published behind it is exposed on its own terms. It is also the reason this index reports what a study observed in the model it studied and declines to say what a compound does.

What does the evidence not show?

Quite a lot, and the limits are as important as the findings.

• Nobody was found liable. Every one of these is a settlement. The Pharmasol decree records that the defendants consented without admitting or denying the allegations in the Complaint and disclaiming any liability in connection therewith. The Justice Department’s own releases say the claims are only allegations and that There has been no determination of liability. A permanently enjoined company has not been found to have done anything.
• None of these is a peptide case or a research-chemical case. Not one. Two are conventional drug manufacturers with manufacturing-practice failures found on inspection, one is a compounding pharmacy that made sterile products, and one sells a cream. A reader who wants to know what happens to a research-compound vendor specifically will not find it here. What transfers is the shape of the remedy, not the facts.
• We read one decree, not four. Only the Pharmasol decree was published as an attachment. The other three are known to us only through the press releases announcing them. Every paragraph quoted here is from that single document, and we have no basis for saying the others are identical — only that the releases describe the same general structure of stopping until conditions are met.
• We did not read any of the complaints. Everything described as alleged is alleged as the Justice Department summarized it in a press release. We did not obtain the underlying pleadings, and a press release is a party’s own account of its own case.
• The releases cite no statutes at all. We checked all four: zero occurrences of U.S.C., zero of C.F.R., and zero of any section number. The authority is named only inside the decree itself, which invokes 21 U.S.C. § 332(a).
• One of the four releases calls the same company two different things. The Vermont complaint is described as naming Edge Pharm Inc., while the FDA official quoted three paragraphs later says Edge Pharma LLC. The docket caption reads United States v. Edge Pharma LLC. We have not resolved which is right.
• We did not check whether any of these companies is trading today. This page is about what the orders say, not about what became of the firms. Nothing here should be read as a statement that any of them is open, closed, or anything in between.
• The verb search is not the lane. 55 releases is the complete result for enjoins, but a second headline formula — obtains injunction — returns 13 more releases, only some of them FDCA cases, that the first search never sees. The real number of FDCA injunction actions is larger than anything one search shows, and we do not know it.

The law behind all of this is 95 words long

The decree says the defendants are permanently restrained and enjoined under 21 U.S.C. § 332(a). That section, read from the United States Code instead of from the decree, is two subsections and about 95 words in total. Subsection (a) gives district courts jurisdiction, for cause shown, to restrain violations of section 331 of this title, except paragraphs (h), (i), and (j). Subsection (b) says that a violation of an injunction is tried by the court, or by a jury if the accused demands one.

That is the entire statutory basis. Eighteen pages of obligations, a five-year audit schedule, an hourly rate card and a $5,000-a-day damages clause all sit on top of one sentence granting a court the power to restrain. Everything that bites was negotiated, not legislated — which is also why reading an actual decree tells you things no summary of the law does.

The carve-outs are worth one line, since they are in the statute’s own text: the injunction power expressly does not reach paragraphs (h), (i) and (j) of section 331. Read from the Code, paragraph (i) is the counterfeiting provision — its third subparagraph covers the sale or dispensing, or the holding for sale or dispensing, of a counterfeit drug. Whatever else the government can do about a counterfeit drug, this particular remedy is not on the list.

What to do with this if you are checking a company

Three practical things come out of it.

An injunction is not in the warning-letter index. If you check a company the way this index recommends — by searching FDA’s warning letter records by name — you will not see a consent decree, because a decree is a court record and not an FDA letter. The two live in different places and neither points at the other. The Justice Department press archive is where the second one is searchable, and the useful search term is the verb.

And the warning letter may not be in the index either. We searched FDA’s own index for all three of the firms whose complaints recite a warning letter. The 2021 letter is there, with its exact issue date. The 2019 letter and the 2017 letter are not findable by company name at all — the searches return other companies. We do not know the rule behind that, and we are not going to invent one; FDA’s general site search sits behind a bot challenge, so we cannot say whether those letters still exist elsewhere on fda.gov. What we can say is the part that matters to a reader: a company returning no results in that index has not been shown to have a clean record. It is consistent with our finding that the downloadable version of the same index is capped at 1,000 rows and unstable between days.

A consent decree is a supervision regime, not necessarily a closure. The Pharmasol decree sets out, in its paragraph 8, the terms on which the company may keep receiving and distributing drugs it does not make — so a company under one of these orders may still be trading. We did not check whether any of these four is operating today, and this page does not say that any of them is. If a supplier disappears or changes hands, the checks worth running include the civil docket, not just the criminal one — and a corporate reorganization is exactly the event a decree like this one requires the company to report in advance.

Sources

• Consent Decree, United States v. Pharmasol Corporation and Marc L. Badia, No. 1:23-cv-12801-AK (D. Mass.), Document 13, filed December 13, 2023, 18 pages — published by the Justice Department as an attachment to its press release. Fetched October 8, 2026, HTTP 200, 2,189,113 bytes. The file contains no text layer: a text extractor returns 1,232 characters for the whole document, all of it the court’s page header stamp, and 0 characters once those stamps are removed. Every quotation above was read from the page images rendered at 150 dpi, and the quoted passages were each read a second time from an independently rendered 400 dpi crop.
• District Court Enjoins Massachusetts Pharmaceutical Manufacturer from Making and Selling Adulterated Drugs, U.S. Department of Justice, Civil Division, December 14, 2023. Body read October 8, 2026.
• Court Enjoins Arizona Company and Its CEO from Manufacturing and Distributing Unapproved Contraceptive Drugs, U.S. Department of Justice, Civil Division, November 15, 2023. Body read October 8, 2026.
• District Court Enjoins Vermont Pharmacy from Distributing Drugs Not Made in Compliance with FDCA, U.S. Department of Justice, Civil Division, June 13, 2022. Body read October 8, 2026.
• District Court Enjoins Illinois Pharmaceutical Manufacturer from Making and Selling Adulterated Drugs, U.S. Department of Justice, Civil Division and U.S. Attorney’s Office for the Northern District of Illinois, August 19, 2022. Body read October 8, 2026.
• How the four releases above were read, since it is not from the pages they link to. Each body was read through the Justice Department’s own press-release data interface, which returns the full text. The ordinary web addresses, linked above because they are what a reader should open, returned an automated-traffic interstitial to our fetcher instead of the release — 2,578 bytes of challenge page with a five-second redirect. A browser passes it; a script does not. The same thing happened at FDA’s general site search, which is why one question further down is left open.
• The census: the Justice Department press-release interface queried for the title term enjoins, October 8, 2026, both pages of results (50 + 5), with the interface’s own reported total of 55; and for obtains injunction, 13 results reported and 13 returned. Both responses archived in full. The division of the 55 into tax, FDCA-shaped and other was done by a rule written before it was applied, and the rule and its output are archived with the responses.
• Docket records for all four cases, read from CourtListener’s public search on October 8, 2026: United States v. Pharmasol Corporation, 1:23-cv-12801 (D. Mass.), filed 2023-11-17, terminated 2023-12-13; United States v. Smart Women’s Choice Incorporated, 2:23-cv-02112 (D. Ariz.), filed 2023-10-12, terminated 2023-11-14; United States v. Morton Grove Pharmaceuticals Inc, 1:22-cv-04367 (N.D. Ill.), filed 2022-08-17, terminated 2022-10-03; United States v. Edge Pharma LLC, 5:22-cv-00109 (D. Vt.), filed 2022-05-20, terminated 2023-11-21.
• FDA Warning Letter 614359, Smart Women’s Choice, issued May 19, 2021, Center for Drug Evaluation and Research. Fetched October 8, 2026, HTTP 200, 40,508 bytes.
• FDA’s searchable warning-letter index, queried by company name on October 8, 2026 for Smart Women (one row, the letter above, issue date 05/19/2021), Pharmasol (one row, a different company) and Morton Grove (one row, a differently named company). All three responses archived.
• 21 U.S.C. § 332, Injunction proceedings, United States Code, 2023 Edition, from the U.S. Government Publishing Office. Fetched October 8, 2026, HTTP 200. The section’s word count and its exception clause were read from these bytes, not from the decree’s citation of it.
• 21 U.S.C. § 331, Prohibited acts, same edition and source, fetched October 8, 2026, HTTP 200. Used only to read what paragraph (i) contains, so that the statement about the exception rests on the Code and not on another page of ours.
• Every interval on this page was computed from the two dates named beside it, and each date was checked against the archived document that carries it before the interval was printed.

COMPLIANCE: This page reports the contents of public U.S. federal court and agency records. It is not legal advice. It makes no claim about any product sold by Artemis Labs or by any other vendor, and it does not state or imply that any compound is safe, effective, or appropriate for any use. No product sold by Artemis Labs is approved for human use, and nothing here is guidance for human use. The companies and individuals named above appear only as parties to public proceedings in which, in every case described, the allegations were resolved by consent with no determination of liability.

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.