FDA Inspection 992904 — K2M, Inc.
The FDA completed an inspection of K2M, Inc. on November 16, 2016 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
- November 16, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Leesburg, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |