FDA Inspection 1048861 — MedSource Labs, LLC
The FDA completed an inspection of MedSource Labs, LLC on Jan 6, 2017 in Chanhassen, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 6, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chanhassen, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |