FDA Inspection 920575 — PWNHealth Chicago LLC.
The FDA completed an inspection of PWNHealth Chicago LLC. on Mar 9, 2015 in Hoffman Estates, IL. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 9, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: 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 |