FDA Inspection 706649 — CareHealth America DBA Express Diagnostics International
The FDA completed an inspection of CareHealth America DBA Express Diagnostics International on January 20, 2011 in Blue Earth, MN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 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 |