FDA Inspection 1016703 — Vygon U.S.A.
The FDA completed an inspection of Vygon U.S.A. on May 25, 2017 in Lansdale, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 25, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lansdale, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |