FDA Inspection
LISI MEDICAL Remmele, IncLISI MEDICAL Remmele, Inc – FDA Inspection, Jul 12, 2022
Record Details
This FDA Inspection record concerns LISI MEDICAL Remmele, Inc, with an inspection on July 12, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- LISI MEDICAL Remmele, Inc
- Inspection Date
- July 12, 2022
- Product Type
- Devices
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ID · 35dd9ded-785c-402f-8e6b-773c6bc32767
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1174227
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.72(b)Remedial action
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Other FDA inspections of LISI MEDICAL Remmele, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2025 | VAI | Minneapolis District Office | Compliance: Medical 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 1268770 - 2025-05-01
- FDA Inspection 1041617 - 2018-01-26
- FDA Inspection 911232 - 2015-01-14
- FDA Inspection 561508 - 2009-02-04
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