FDA Inspection 650453 — Physio PS, Inc.
The FDA completed an inspection of Physio PS, Inc. on February 16, 2010 in Londonderry, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 16, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Londonderry, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |