FDA Inspection 863704 — Physio-Control, Inc.
The FDA completed an inspection of Physio-Control, Inc. on January 17, 2014 in Redmond, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 17, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Redmond, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4252 | 21 CFR 821.25(c)(3) | Quality assurance procedures: 6-month & annual audits |