FDA Inspection 925958 — Chr-Hansen - Wausau

Chr-Hansen - Wausau — FEI 3004060046

The FDA completed an inspection of Chr-Hansen - Wausau on May 13, 2015 in Wausau, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 13, 2015
Fiscal Year
2015
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Wausau, WI (United States)

Citations

IDCFRDescription
1546821 CFR 111.20(c)(2)Physical plant - material review and disposition
1553321 CFR 111.255(c)Batch record - follow master
1573421 CFR 111.360Manufacturing operations - sanitation
1573721 CFR 111.210(h)(5)Corrective action plans
1574421 CFR 111.210(h)(2)Master manufacturing record - sampling, tests, examinations
1574621 CFR 111.210(h)(1)Instructions; specifications; quality
1574721 CFR 111.210(g)Packaging description, representative label
1587221 CFR 111.75(c)(3)Specifications met identity,purity, strength, comp,; basis