FDA Inspection 577818 — Vygon MFG, Inc.
The FDA completed an inspection of Vygon MFG, Inc. on Feb 18, 2009 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 18, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dover, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3693 | 21 CFR 820.100(a)(5) | Implementing changes |
| 538 | 21 CFR 820.70(a) | Process control procedures |