Consent Decree of Permanent Injunction
A consent decree of permanent injunction is a court order entered by agreement between FDA/DOJ and a device manufacturer, requiring the company to stop violative manufacturing operations and undertake extensive corrective measures under court and FDA oversight.
How a consent decree arises
The typical escalation path:
FDA inspection → 483 observations
↓
Inadequate 483 response
↓
Warning letter issued (publicly posted)
↓
Inadequate warning letter response / continued violations
↓
FDA refers to DOJ for injunction
↓
DOJ files complaint in federal court
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Company negotiates consent decree with DOJ/FDA
(or court imposes injunction after trial)
↓
Consent decree entered by court
In practice, the vast majority of consent decrees are negotiated — companies rarely litigate against injunctions given FDA's strong track record in court.
What a consent decree typically requires
| Requirement | Description |
|---|---|
| Cease manufacturing | Stop manufacturing and distributing affected products immediately |
| Third-party expert | Engage an FDA-approved independent expert (third-party auditor/consultant) |
| Remediation plan | Submit a detailed plan to FDA and the court for corrective actions |
| Expert certification | Before resuming, the independent expert must certify that the QMS meets requirements |
| Ongoing oversight | Third-party expert conducts periodic audits; reports to FDA and the court |
| Civil penalties | Significant daily fines if the company violates the consent decree |
| Annual reports | Submit annual compliance reports to FDA and the court |
Impact on business
Consent decrees have severe commercial consequences:
- Manufacturing halts mean lost revenue and customer loss
- Public posting of the consent decree damages brand reputation
- The independent expert and remediation process are extremely expensive
- Customers (hospitals, distributors) may be legally required to return affected products
- Other global regulatory authorities may take parallel actions in their jurisdictions
Path to exit from a consent decree
Exiting a consent decree (termination of the court order) requires:
- Sustained demonstration of QMS compliance over time
- Expert certification of compliance
- FDA agreement to seek termination from the court
- Court order terminating the consent decree
This typically takes 2–5 years or longer, even after achieving demonstrable QMS compliance, because FDA and the court must be satisfied that compliance is sustained and not merely temporary.