TL;DR
- A consent decree of permanent injunction is a federal court order, negotiated between a company, DOJ, and FDA, that can keep a facility closed until an independent expert certifies it's back in compliance — the same statutory injunction authority FDA has held since 21 U.S.C. § 332 (FDA Regulatory Procedures Manual, Ch. 6: Judicial Actions).
- Pharmasol Corporation's route from a 2019 Warning Letter to a December 2023 consent decree, over the same unresolved CGMP failures, shows how long that path can run (FDA press release, Dec. 14, 2023).
- Once entered, the company pays for every follow-up inspection FDA conducts, at up to 267% of a GS-11 investigator's hourly rate, and stays closed until its own hired expert certifies compliance and FDA agrees in writing (FDA RPM Ch. 6, §§ 6-2-14, 6-2-15).
What is an FDA consent decree, and where does it sit on the enforcement ladder?
Congress gave FDA the authority to seek an injunction under 21 U.S.C. § 332 in the Food, Drug & Cosmetic Act itself, long before "Warning Letter" was a phrase any quality department used routinely. That's the historical parallel worth sitting with: the courtroom tool FDA reaches for today is the same statutory authority the agency has held since the Act's earliest injunction provisions (FDA RPM Ch. 6, § 6-2-2). What's evolved is everything that happens before FDA decides to use it.
A consent decree of permanent injunction is a negotiated settlement, filed as a complaint for injunction and entered by a federal judge, in which a company agrees to stop manufacturing or distributing a product until it meets conditions FDA and DOJ write into the decree (FDA RPM Ch. 6, §§ 6-2-3, 6-2-13). It's one of three injunction outcomes in FDA's manual: a temporary restraining order (an immediate 10-day emergency stop), a preliminary injunction (can stand while a case proceeds), or a permanent injunction, which stays in force until a court dissolves it, by consent or after trial (FDA RPM Ch. 6, § 6-2-3).
Step 1-3: inspection, Warning Letter, the repeat finding
The path almost never starts with a lawsuit. It starts with an inspection, a Form 483, and, if FDA decides the violations meet the threshold, a Warning Letter. Pharmasol Corporation, a Massachusetts drug manufacturer, got exactly that sequence: a 2019 Warning Letter over unfollowed complaint-handling procedures. FDA's own account of what happened next is blunt: a 2022 inspection "found the majority of the inspectional observations repeated those found in past FDA inspections" (FDA press release, Dec. 14, 2023).
That repeat finding is the hinge point. FDA's guidance says an injunction becomes the likelier next step when a firm has "a history of violations, and has promised correction in the past, but has not made the corrections" (FDA RPM Ch. 6, § 6-2-2). A single Warning Letter rarely escalates straight to a consent decree; a second inspection documenting the same unresolved problems usually does.
Step 4-6: DOJ referral, complaint, and the decree
Once FDA decides violations are "long-standing (chronic)... and have not been corrected through use of voluntary or other regulatory approaches," it can refer the case for an injunction instead of another Warning Letter (FDA RPM Ch. 6, § 6-2-4). FDA's Office of Chief Counsel prepares the case, DOJ files a complaint for injunction in federal court, and in most cases the company settles rather than going to trial, agreeing to a decree instead of contesting the evidence (FDA RPM Ch. 6, § 6-2-13).
Pharmasol's decree was entered December 14, 2023, four years after the original Warning Letter, ordering the company and its president to stop distributing drugs until they meet its requirements (FDA press release, Dec. 14, 2023). A faster example: AniCell Biotech LLC, an Arizona animal-drug maker warned by FDA over unapproved products, had its decree entered April 17, 2025 (DOJ press release, April 29, 2025).
| Pharmasol Corporation | AniCell Biotech LLC | |
|---|---|---|
| Product type | OTC/prescription drugs | Animal cell/tissue-based products |
| FDA warning | 2019 Warning Letter | Prior written warning letter |
| Repeat finding | 2022 inspection repeated citations | Cited across several inspections |
| Decree entered | December 14, 2023 | April 17, 2025 |
| Core requirement | Stop distribution until compliant | Destroy product, cease operations until compliant |
Step 7-8: who pays, and how a firm reopens
A consent decree doesn't end a company's relationship with FDA; it restructures it. A firm typically must hire an independent expert consultant, at its own cost, who certifies in writing that the company has met the decree's terms before FDA will schedule a reinspection. FDA doesn't pre-approve the consultant, but can reject findings that look incomplete, conflicted, or inconsistent with CGMP requirements such as 21 CFR 211.22 (FDA RPM Ch. 6, § 6-2-15).
The company also pays for every inspection FDA conducts under the decree, at 267% of a GS-11/4 hourly rate for investigation time and 267% of a GS-12/4 rate for analytical time, plus per diem and miscellaneous costs (FDA RPM Ch. 6, § 6-2-14). Operations stay closed until FDA agrees, in writing, that conditions are met, regardless of what the company's own consultant has already certified (FDA RPM Ch. 6, §§ 6-2-14, 6-2-15).
FAQ
Is a consent decree the same thing as an injunction?
A consent decree is one way an injunction case can end. A consent decree of permanent injunction is a permanent injunction the defendant agreed to rather than contested at trial (FDA RPM Ch. 6, § 6-2-3).
How long does it take to go from a Warning Letter to a consent decree, and does every decree follow one?
There's no fixed timeline; Pharmasol's path ran roughly four years, with a repeat inspection in between, since evidence has to stay current for an injunction case to hold up (FDA RPM Ch. 6, § 6-2-2). Prior notice isn't a legal requirement, but FDA's guidance says a firm's documented failure to correct after notice strengthens the case, which is why most decrees follow at least one prior Warning Letter or inspection notice (FDA RPM Ch. 6, § 6-2-5).
Who decides when a firm can resume operations after a consent decree?
FDA does, in writing, after an independent expert the firm retains certifies compliance and FDA's own reinspection confirms it. The firm's consultant doesn't have unilateral authority to reopen operations (FDA RPM Ch. 6, § 6-2-15).
Related reading
- What's the difference between a Form 483 and an FDA Warning Letter?
- What actually makes an FDA warning letter response "adequate" enough to close out?
- What is an FDA Import Alert, and what does DWPE mean?
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Sources: FDA Regulatory Procedures Manual, Chapter 6: Judicial Actions, FDA press release, "Federal Court Enters Consent Decree Against Pharmasol for Distributing Adulterated Drugs," Dec. 14, 2023, U.S. Department of Justice, "Court Enjoins Arizona Animal Drug Manufacturer from Distributing Unapproved Drugs," April 29, 2025. Byline: The Argus Regulatory Analysis Team. Published 2026-07-11.