FDA Inspection 949582 — CareHealth America DBA Express Diagnostics International
The FDA completed an inspection of CareHealth America DBA Express Diagnostics International on September 25, 2015 in Blue Earth, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 25, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Blue Earth, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |