LISI MEDICAL Remmele FDA Inspection Record
LISI MEDICAL Remmele is an FDA-registered facility (FEI 3000203391) located in Coon Rapids, MN, US. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- May 1, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (2 VAI, 3 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 1, 2025 | Voluntary Action Indicated (VAI) | Training - Lack of or inadequate procedures (21 CFR 820.25(b)) Lack of or inadequate procedures (21 CFR 820.100(a)) |
| Jul 12, 2022 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures - Acceptance activities (21 CFR 820.80(a)) Remedial action (21 CFR 820.72(b)) |
| Jan 26, 2018 | No Action Indicated (NAI) | No citations listed |
| Jan 14, 2015 | No Action Indicated (NAI) | No citations listed |
| Feb 4, 2009 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- LISI MEDICAL Remmele, Inc.
- Location
- Coon Rapids, MN (US)
- Source
- device