FDA Inspection 547939 — 21St Century Scientific Inc
The FDA completed an inspection of 21St Century Scientific Inc on Oct 29, 2008 in Coeur d Alene, ID. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Oct 29, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Coeur d Alene, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |