FDA Inspection
LISI MEDICAL Remmele, IncLISI MEDICAL Remmele, Inc – FDA Inspection, Apr 27, 2023
Record Details
This FDA Inspection record concerns LISI MEDICAL Remmele, Inc, with an inspection on April 27, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8a42ee05-e6b2-4e55-b07e-f62e1b77c7ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1203796
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of LISI MEDICAL Remmele, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 14, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for LISI MEDICAL Remmele, Inc
- FDA Inspection 1041633 - 2018-01-18
- FDA Inspection 910759 - 2015-01-14
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