Seizure, Injunction & Criminal Prosecution
These are FDA's most powerful enforcement tools, used when voluntary compliance fails or when public health requires immediate action.
1. Seizure — FD&C Act § 304
Seizure allows FDA to physically remove violative goods (adulterated or misbranded devices) from commerce. FDA does not have independent seizure authority — it must work through the Department of Justice (DOJ) and the US Marshals Service.
How seizure works
- FDA identifies violative devices in commerce
- FDA refers the matter to DOJ with a recommendation for seizure
- DOJ files a civil action in federal district court (e.g., United States v. [Quantity] [Device Name])
- Court issues a warrant of arrest for the goods
- US Marshals execute the seizure — physically taking possession of the goods
- Claimant (typically the manufacturer) has 30 days to contest the seizure
- If unchallenged, the goods are condemned and destroyed or recalled
Grounds for seizure
- Device is adulterated (e.g., manufactured in violation of QMSR)
- Device is misbranded (e.g., inadequate labelling, false claims)
- Device is being offered for sale without required clearance/approval
2. Injunction — FD&C Act § 302
An injunction is a court order requiring a company to stop a violative activity (permanent injunction) or to take specific corrective actions. FDA seeks injunctions through DOJ.
Types of injunctions
| Type | Description |
|---|---|
| Temporary restraining order (TRO) | Immediate, short-term halt pending a hearing |
| Preliminary injunction | Halt during litigation |
| Permanent injunction | Long-term court order; often called a "consent decree" when the company agrees |
Consequences of a permanent injunction
- Must cease manufacturing of violative devices
- Must implement FDA-approved remediation plan
- Must engage FDA-approved independent expert for oversight
- Must achieve expert certification before resuming manufacturing
- Subject to civil penalties for future violations
3. Criminal Prosecution — FD&C Act § 303
Criminal prosecution is reserved for the most serious violations — particularly wilful violations or cases involving serious patient harm.
Standards for criminal liability
| Violation type | Standard | Maximum penalty |
|---|---|---|
| Misdemeanour (non-wilful) | No intent required — strict liability for responsible corporate officials | 1 year / fine |
| Felony (wilful) | Must prove the defendant knowingly committed the violation | 3 years / larger fine |
The "responsible corporate officer" doctrine
Under the Park doctrine (US v. Park, 1975), corporate officers may be criminally liable for violations committed by their company even without personal knowledge of the violation — if they had authority to prevent or correct the violation. This applies to FDA device cases.