What Is a Consent Decree? FDA Consent Decrees Explained, With Examples

A consent decree is a court order that a company and the government agree to instead of going to trial; in FDA cases, the Department of Justice files a complaint on FDA's behalf and the company consents to a decree of permanent injunction that stops or limits its operations until it proves compliance. The judge signs it, so breaking it is contempt of court, not just another regulatory finding.

Consent decrees are the top of FDA's enforcement ladder. They are rare, they come after years of Form 483s and warning letters, and they last at least five years. This guide, updated October 2026, explains how a firm gets there, what a decree requires, how decrees end, and what the inspection record looked like at three facilities in the year before a decree, using the Atlas facility records (release of August 15, 2026).

Key facts

• An FDA consent decree is a decree of permanent injunction under 21 U.S.C. 332, entered by a federal district court after the Department of Justice files a complaint at FDA's request.
• FDA's Regulatory Procedures Manual, Chapter 6, says a permanent injunction remains in effect until a court order dissolves it.
• FDA will consider not opposing a motion to vacate only after continuous compliance for the life of the sunset provision, which the manual says is "virtually always five years".
• Under FDA's manual, every injunction resolved by consent decree should make the company pay for each inspection made under the decree, with investigator time billed at 267% of the GS-11, step 4 hourly rate.
• The Philips Respironics facility in Murrysville, Pennsylvania had 14 FDA inspections and 4 Form 483s on record before its April 9, 2024 decree.
• At Pharmasol Corporation in South Easton, Massachusetts, 21 CFR 211.192 (investigations) appears on 6 of the 8 Form 483s Atlas holds for the facility before its December 2023 decree.

What is an FDA consent decree of permanent injunction?

An FDA consent decree of permanent injunction is a negotiated court order that bars a company, and usually named executives, from making or shipping FDA-regulated products until it meets conditions written into the decree. The government files a complaint for injunction; the company agrees to the decree rather than contest it; the court enters it.

FDA's Regulatory Procedures Manual, Chapter 6 (Judicial Actions) sets out the mechanics. An injunction is "a civil judicial process initiated to stop or prevent violation of the law" (section 6-2-2). A decree of permanent injunction "may be entered at any time after the complaint is filed, either following a hearing or as a result of a negotiated settlement" (6-2-3 C). FDA's Office of Chief Counsel drafts the decree, the relevant center supplies the technical terms, and DOJ files it.

Three features separate a consent decree from everything below it on the ladder. A judge enforces it. It names individuals, often the CEO or president, as defendants. And it does not expire on its own.

How does a company end up under a consent decree?

A company ends up under a consent decree after FDA concludes that warning letters and voluntary action have not fixed a problem, or that a health hazard needs a court order now. The usual path runs through repeat Form 483s, an inspection classified Official Action Indicated (OAI), a warning letter, often an import alert for foreign sites, and then a DOJ complaint.

The manual says an injunction is more likely to succeed when "a firm has a history of violations, and has promised correction in the past, but has not made the corrections", and that the evidence must be current. That is why decrees usually follow a recent inspection, not an old one.

Our guides to the FDA untitled letter and to FDA violations and warning letters cover the middle rungs. The step most firms can still control is the first one: the Atlas record holds 148,507 inspections that ended with a Form 483, and among 90 recent human-drug 483s, 21 CFR 211.192 appears on 31% (Atlas Form 483 directory, data to July 2026). That is the same section that repeats across the Pharmasol record below. Our comparison of a Form 483 response vs a warning letter response explains where each one fails.

Ranbaxy shows the full ladder. FDA issued warning letters and an import alert for its Dewas and Paonta Sahib facilities in September 2008, invoked its Application Integrity Policy in 2009, and DOJ filed a consent decree of permanent injunction on January 25, 2012.

What does an FDA consent decree require?

An FDA consent decree requires the company to stop, or sharply limit, manufacturing and distribution at the named facilities until an independent expert certifies that the problems are fixed and FDA confirms compliance in writing. Most decrees add payment for FDA's oversight costs and financial penalties for missed deadlines.

FDA does not approve the expert. The manual says FDA "does not approve or disapprove of experts selected by defendants", but it can refuse to accept an expert's report if it is incomplete, conflicted or below the standard in 21 CFR 211.22.

Which companies have been under an FDA consent decree?

The companies below entered FDA consent decrees announced by FDA or the Department of Justice between 2012 and 2024. Each row is taken from an fda.gov or justice.gov announcement.

The Abbott decree followed the 2022 Cronobacter investigation and let the Sturgis facility restart under expert oversight. The Philips decree followed the June 2021 recall of about 15 million devices worldwide; it also required a recall remediation plan with replacement devices or partial refunds for patients.

What did the inspection record look like before the decree?

The inspection record before a consent decree typically shows years of Form 483s at the same facility, the same regulation cited again and again, and one recent event that made court action urgent. Atlas holds the inspection history for three of the facilities in the table above (release of August 15, 2026).

Philips Respironics, Murrysville, Pennsylvania. Atlas records 14 FDA inspections and 4 Form 483s at the facility, in June 2011, April 2014, November 2021 and May 2022. The two most recent carry 12 of the facility's 16 recorded observations. 21 CFR 820.100(a), corrective and preventive action, appears four times: in 2011, in 2021 and twice in 2022. The November 2021 483 also cites 806.10(a)(1), failure to report a correction made to reduce a risk to health, the same violation FDA named in the decree complaint. Investigator Katelyn A Staub-Zamperini took part in 7 of the 14 inspections, including those that produced the 2011, 2014 and 2021 483s.

Pharmasol Corporation, South Easton, Massachusetts. Atlas records 11 inspections, 8 of which ended with a Form 483, every inspection from September 2011 to February 2022. The 483s carry 97 observations. 21 CFR 211.192 is cited 10 times across six of them, and 211.22(d), quality unit procedures, 8 times. Atlas classifies the 2018 inspection as leading to a warning letter; FDA's decree announcement says the 2019 letter cited leaking containers the company failed to investigate, and that most observations at the 2022 inspection repeated earlier ones. Sean R Marcsisin was on the 2018, 2021 and 2022 inspections. The decree came 22 months after the last 483.

Rizo Lopez Foods, Modesto, California. The Rizo Lopez Foods facility record shows 9 inspections before the October 2024 decree, with Form 483s in 2011, 2016 and February 2024. FDA's announcement says the February 2024 inspection was followed by finding the outbreak strain of Listeria monocytogenes in the facility environment, linked to 26 illnesses in 11 states and 2 deaths. Inspections continued under the decree: a clean inspection in April 2025, then 483s in October 2025 and March 2026 citing 21 CFR 117.135(a)(1), sanitation preventive controls, with investigator Lilia K Vazquez on both.

None of the three decrees came from a single bad inspection: each facility had its first Form 483 on record more than a decade earlier. You can pull the same history for any supplier from the FDA facility lookup.

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How long does an FDA consent decree last?

An FDA consent decree lasts until a court dissolves it, and in practice at least five years after the company returns to compliance. The shutdown phase can be a few months or several years; the oversight phase after that is set by the decree's sunset provision, which FDA's manual says is "virtually always five years".

The manual (section 6-2-16) says FDA does not ask the court to vacate a decree and will not join a motion to do so. It may agree not to oppose the company's motion if three things are true: FDA has recent evidence of compliance, typically from an inspection in the last 6 to 8 months; the company has been in continuous compliance for the whole sunset period; and FDA has had the chance to review the motion. A long violation history counts against the company.

Three cases show the range:

1. Cantrell Drug Company, Little Rock. The decree was entered April 19, 2018. Atlas records a reinspection from August 13 to 22, 2018 that still produced a Form 483 with three observations, and the company resumed operations later that year after FDA wrote that it appeared to comply. The shutdown lasted months; the decree did not end.
2. Ranbaxy, later Sun Pharma, Mohali, India. FDA added the Mohali facility under the 2012 decree in September 2013, sent a resume-operations letter on March 14, 2017, and sent a non-compliance letter on May 4, 2023. The decree outlived an acquisition and more than a decade.
3. STERIS. The company reported that a federal court in Ohio terminated its 2010 decree on July 8, 2015, on an unopposed motion citing five years of continuous compliance. That is the standard exit.

Our analysis of how warning letters affect later inspection outcomes covers the step before a decree, and the NAI, VAI and OAI guide explains the classification that starts the escalation.

Consent decree vs warning letter: what is the difference?

A warning letter is FDA's own written notice of significant violations and carries no court order; a consent decree is a judgment entered by a federal court that can halt operations and is enforced by contempt. A warning letter asks for a response in 15 business days. A consent decree sets binding deadlines, names executives personally, and stays on the court docket for years.

The practical difference is who decides when you restart. After a warning letter, the company decides how to fix the problem and FDA judges the result at the next inspection. Under a decree, the decree decides the steps, an independent expert certifies them, and nothing ships until FDA says so in writing.

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