FDA Inspection
Elcam Medical Italy SPAElcam Medical Italy SPA – FDA Inspection, Sep 22, 2011
Record Details
This FDA Inspection record concerns Elcam Medical Italy SPA, with an inspection on September 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Elcam Medical Italy SPA
- Inspection Date
- September 22, 2011
- Product Type
- Devices
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ID · 2af489f2-cf64-447b-8416-562f7d6c9b25
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 747430
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Elcam Medical Italy SPA
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 31, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 9, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Elcam Medical Italy SPA
- FDA Inspection 1195406 - 2022-12-14
- FDA Inspection 1060877 - 2018-05-31
- FDA Inspection 597361 - 2009-07-09
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