FDA Inspection 943068 — Performance Health Systems LLC
The FDA completed an inspection of Performance Health Systems LLC on Sep 24, 2015 in Northbrook, 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 24, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Northbrook, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |