FDA Inspection
LISI MEDICAL Remmele, IncLISI MEDICAL Remmele, Inc – FDA Inspection, May 1, 2025
Record Details
This FDA Inspection record concerns LISI MEDICAL Remmele, Inc, with an inspection on May 1, 2025, issued by the Minneapolis District Office, covering medical devices & rad health.
View Company Profile
ID · 9a561997-957d-4c6d-8bcb-c65efa5c17d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1268770
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of LISI MEDICAL Remmele, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 26, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 14, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 4, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for LISI MEDICAL Remmele, Inc
- FDA Inspection 1174227 - 2022-07-12
- FDA Inspection 1041617 - 2018-01-26
- FDA Inspection 911232 - 2015-01-14
- FDA Inspection 561508 - 2009-02-04
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.