FDA Inspection
Orthofix SrlOrthofix Srl – FDA Inspection, Sep 27, 2012
Record Details
This FDA Inspection record concerns Orthofix Srl, with an inspection on September 27, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Orthofix Srl
- Inspection Date
- September 27, 2012
- Product Type
- Devices
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ID · 5f983a07-e9bf-4baa-ab74-eab4f844857b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 802729
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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