813351
Fresenius Medical Care North America - Texas — FEI 3003310249
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 7, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Irving, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |