920575
PWNHealth Chicago LLC. — FEI 3000206414
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 9, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hoffman Estates, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |