FDA Inspection
Esaote S.p.A.Esaote S.p.A. – FDA Inspection, Dec 2, 2010
Record Details
This FDA Inspection record concerns Esaote S.p.A., with an inspection on December 2, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Esaote S.p.A.
- Inspection Date
- December 2, 2010
- Product Type
- Devices
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ID · fa994981-a1e9-4bfc-a61b-a67e91663b2a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 701345
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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