FDA Inspection 1177676 — Mendell Machine and Manufacturing LLC
The FDA completed an inspection of Mendell Machine and Manufacturing LLC on August 3, 2022 in Lakeville, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 3, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lakeville, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |