FDA Inspection 576034 — Physio-Control, Inc.
The FDA completed an inspection of Physio-Control, Inc. on Mar 30, 2009 in Redmond, WA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 30, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Redmond, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |
| 3689 | 21 CFR 820.100(a)(2) | Investigation |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |