FDA Inspection 859431 — Smart Medical Technology Inc
The FDA completed an inspection of Smart Medical Technology Inc on Dec 17, 2013 in Darien, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Dec 17, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Darien, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 2339 | 21 CFR 820.22 | Quality Audit/Reaudit - documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |