FDA Inspection 1203796 — LISI MEDICAL Remmele, Inc
The FDA completed an inspection of LISI MEDICAL Remmele, Inc on Apr 27, 2023 in Big Lake, 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 27, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Big Lake, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |