FDA Inspection 735332 — Vygon MFG, Inc.
The FDA completed an inspection of Vygon MFG, Inc. on Jul 28, 2011 in Dover, NH. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 28, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dover, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |