FDA Inspection 1019366 — Mizkan America, Inc.

Mizkan America, Inc. — FEI 3011021015

The FDA completed an inspection of Mizkan America, Inc. on Mar 30, 2017 in Owensboro, KY. 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: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Mar 30, 2017
Fiscal Year
2017
Product Type
Food/Cosmetics
Project Area
Foodborne Biological Hazards
Location
Owensboro, KY (United States)

Citations

IDCFRDescription
133021 CFR 113.100(a)Process records - forms missing information
1815121 CFR 117.40(f)Instruments and Controls
250321 CFR 113.40(e)(2)(iii)Unauthorized adjustment
418121 CFR 113.89Process deviation identification

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.