FDA Inspection 863171 — Integra LifeSciences Corporation - Integra Burlington
The FDA completed an inspection of Integra LifeSciences Corporation - Integra Burlington on January 22, 2014 in North Billerica, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 22, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- North Billerica, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3118 | 21 CFR 820.75(a) | Documentation |