FDA Inspection 706370 — K2M, Inc.
The FDA completed an inspection of K2M, Inc. on January 18, 2011 in Leesburg, VA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 18, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Leesburg, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |