FDA Inspection 807257 — Advanced Renal Technologies Inc
The FDA completed an inspection of Advanced Renal Technologies Inc on Nov 16, 2012 in Bellevue, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 16, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bellevue, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |