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
↓
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 several years even after achieving compliance.