FDA Inspection 1198065 — Black Forest Medical North America Inc
The FDA completed an inspection of Black Forest Medical North America Inc on February 15, 2023 in Cape Coral, FL. 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
- February 15, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cape Coral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 4493 | 21 CFR 803.42(e)(1) | Whether reporter is an importer |