FDA Inspection 1174227 — LISI MEDICAL Remmele, Inc.
The FDA completed an inspection of LISI MEDICAL Remmele, Inc. on Jul 12, 2022 in Coon Rapids, 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
- Jul 12, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Coon Rapids, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3237 | 21 CFR 820.72(b) | Remedial action |