FDA Inspection
Eltech s.r.l.Eltech s.r.l. – FDA Inspection, Aug 29, 2014
Record Details
This FDA Inspection record concerns Eltech s.r.l., with an inspection on August 29, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Eltech s.r.l.
- Inspection Date
- August 29, 2014
- Product Type
- Devices
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ID · 82be19e0-6e52-429d-92e4-8cdeb9180868
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 894884
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 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 820.90(a)Nonconforming product control
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Other FDA inspections of Eltech s.r.l.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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