786007
Integra LifeSciences Corporation — FEI 1121308
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 30, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Plainsboro, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 812 | 21 CFR 803.56 | Submission of Supplement to Individual Report Within One Month |