FDA Inspection 790503 — Westone Laboratories, Inc.
The FDA completed an inspection of Westone Laboratories, Inc. on Jul 12, 2012 in Colorado Springs, CO. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 12, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Colorado Springs, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |