FDA Inspection
Leventon S. A. U.Leventon S. A. U. – FDA Inspection, Mar 22, 2018
Record Details
This FDA Inspection record concerns Leventon S. A. U., with an inspection on March 22, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a8c6339a-a163-4f66-86fd-df81aa6b299e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1046509
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Leventon S. A. U.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 24, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Leventon S. A. U.
- FDA Inspection 945390 - 2015-09-24
- FDA Inspection 716215 - 2011-02-24
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