FDA Inspection
Vygon U.S.A.Vygon U.S.A. – FDA Inspection, May 25, 2017
Record Details
This FDA Inspection record concerns Vygon U.S.A., with an inspection on May 25, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · da75f1d5-947a-4285-b696-7db67d99d083
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016703
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Complaints
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Other FDA inspections of Vygon U.S.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 14, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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