FDA Inspection 945497 — Shikani Medical, LLC
The FDA completed an inspection of Shikani Medical, LLC on Oct 9, 2015 in Lutherville, MD. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Oct 9, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lutherville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |