FDA Inspection 1174723 — Key Surgical LLC
The FDA completed an inspection of Key Surgical LLC on July 18, 2022 in Eden Prairie, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 18, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Eden Prairie, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |