FDA Inspection Types & Authority
| Inspection type | Trigger | Key focus |
|---|---|---|
| Surveillance | Routine, periodic | QMSR compliance |
| Pre-approval (PAI) | Before PMA approval | Data integrity, manufacturing |
| For-cause | MDR trends, complaints | Specific issue |
| Follow-up | Previous 483 observations | Corrective actions |
| Unannounced | FDA discretion | Overall compliance |
See FDA Inspections & Warning Letters in the Quality System section for full detail.
Official resources
FDA Inspection Authority
FDA's authority to inspect device manufacturers derives from FD&C Act § 704. FDA may inspect any establishment that manufactures, processes, packs, or holds a device. Inspections may occur without advance notice. Manufacturers must permit FDA inspectors access to all records, facilities, and equipment relevant to device compliance. Refusal to permit inspection is itself a violation.