868020
Terumo Cardiovascular Systems Corporation — FEI 1828100
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 17, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ann Arbor, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |