FDA Inspection
IMS GIOTTO S.p.A.IMS GIOTTO S.p.A. – FDA Inspection, Dec 12, 2013
Record Details
This FDA Inspection record concerns IMS GIOTTO S.p.A., with an inspection on December 12, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- IMS GIOTTO S.p.A.
- Inspection Date
- December 12, 2013
- Product Type
- Devices
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ID · 1f241d98-59bd-467a-9aec-0e0e826b0c4a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 859900
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of IMS GIOTTO S.p.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2014 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for IMS GIOTTO S.p.A.
- FDA Inspection 907150 - 2014-12-04
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