FDA Inspection 799848 — Integra Lifesciences (Ireland) Limited
The FDA completed an inspection of Integra Lifesciences (Ireland) Limited on Aug 23, 2012 in SRAGH Tullamore. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 23, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- SRAGH Tullamore (Ireland)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |