FDA Inspection
Quanta System SpAQuanta System SpA – FDA Inspection, Apr 19, 2012
Record Details
This FDA Inspection record concerns Quanta System SpA, with an inspection on April 19, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Quanta System SpA
- Inspection Date
- April 19, 2012
- Product Type
- Devices
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ID · fa56de90-ad80-4308-a46b-58682c6ea057
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 780939
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
15- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - 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 Quanta System SpA
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 1, 2017 | Not classified | Office of Inspections and Investigations |
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