FDA Inspection 706649 — CareHealth America
The FDA completed an inspection of CareHealth America on Jan 20, 2011 in Blue Earth, MN. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 20, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Blue Earth, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |