FDA Inspection 760634 — ONETIK

ONETIK — FEI 3004265685

The FDA completed an inspection of ONETIK on Dec 2, 2011 in Macaye. 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). 5 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
Dec 2, 2011
Fiscal Year
2012
Product Type
Food/Cosmetics
Project Area
Foodborne Biological Hazards
Location
Macaye (France)

Citations

IDCFRDescription
112521 CFR 110.40(a)Materials and workmanship
142421 CFR 110.20(b)(4)Drip and condensate
158121 CFR 110.37(e)Running water at suitable temperature
169521 CFR 110.80(b)(2)Manufacturing conditions
169821 CFR 110.80(b)(5)Work-in-progress

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