Food and Drug Administration (FDA)
The FDA enforces federal laws governing the safety and efficacy of drugs, medical devices, biologics, food products, cosmetics, and tobacco. Its Office of Criminal Investigations pursues criminal violations, while the Office of Regulatory Affairs conducts inspections and brings administrative actions. The agency issues warning letters, import alerts, consent decrees, and product seizures.
Back to all agenciesWarning Letters Issued
4,820
Cases Per Year
1,224
Import Alerts
1,150
Product Recalls
3,690
Facility Inspections
15,200
Cases Filed (Annual)
Penalties Collected Trend ($M)
Top Enforcement Actions
| Action | Respondent | Date | Amount | Type |
|---|---|---|---|---|
| Opioid Misbranding and Distribution | Purdue Pharma L.P. | 2020-10-21 | $8.3B | Criminal Fine |
| Adulterated Drug Manufacturing (cGMP) | Philidor Rx Services | 2022-08-15 | $45M | Settlement |
| Unauthorized Marketing of Medical Device | Bayer AG (Essure) | 2023-01-19 | $1.6B | Settlement |
| Food Safety Modernization Act Violations | Blue Bell Creameries | 2023-05-10 | $19.4M | Criminal Penalty |
| Tobacco Product Marketing to Minors | JUUL Labs Inc. | 2022-06-23 | $438.5M | Settlement |
Enforcement Topics
Drug SafetyMedical DevicesFood SafetyTobacco RegulationcGMP ComplianceBiologics