FDA Inspection 646649 — Integra LifeSciences Corporation
The FDA completed an inspection of Integra LifeSciences Corporation on Jan 20, 2010 in Salt Lake City, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 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 |