FDA Inspection 1271166 — Mendell Machine And Manufacturing LLC
The FDA completed an inspection of Mendell Machine And Manufacturing LLC on May 30, 2025 in Lakeville, 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 30, 2025
- Fiscal Year
- 2025
- 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. |