FDA Inspection 550159 — Cobeg Inc
The FDA completed an inspection of Cobeg Inc on Dec 4, 2008 in Goleta, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 4, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Goleta, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3328 | 21 CFR 820.180(b) | Retention period |
| 4189 | 21 CFR 820.198(a) | General |
| 542 | 21 CFR 820.70(c) | Environmental control system periodic inspections |