FDA Inspection 1037046 — MIE America, Inc.
The FDA completed an inspection of MIE America, Inc. on January 8, 2018 in Elk Grove Village, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 8, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Elk Grove Village, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |