FDA Inspection 703632 — Ciba Vision Corporation

Ciba Vision Corporation — FEI 1000115040

The FDA completed an inspection of Ciba Vision Corporation on Dec 22, 2010 in Des Plaines, IL. 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
Dec 22, 2010
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Des Plaines, IL (United States)

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
312821 CFR 820.90(a)Nonconforming product control
369621 CFR 820.100(b)Documentation