FDA Inspection
Leventon S. A. U.Leventon S. A. U. – FDA Inspection, Feb 24, 2011
Record Details
This FDA Inspection record concerns Leventon S. A. U., with an inspection on February 24, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Leventon S. A. U.
- Inspection Date
- February 24, 2011
- Product Type
- Devices
View Company Profile
ID · cda85ee8-b6cf-4b09-ac47-42db9351972f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 716215
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Leventon S. A. U.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2018 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 24, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Leventon S. A. U.
- FDA Inspection 1046509 - 2018-03-22
- FDA Inspection 945390 - 2015-09-24
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