FDA Inspection 734697 — Ciba Vision GmbH
The FDA completed an inspection of Ciba Vision GmbH on Jun 30, 2011 in Groswallstadt. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 30, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Groswallstadt (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 537 | 21 CFR 820.70(a) | Production processes |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |