646649
Integra LifeSciences Corporation — FEI 1000138491
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 20, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3397 | 21 CFR 820.80(d)(2) | Review of data and documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 538 | 21 CFR 820.70(a) | Process control procedures |