807793

Tonic Life S de RL — FEI 3008228330

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 13, 2012
Fiscal Year
2013
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Irapuato (Mexico)

Citations

IDCFRDescription
1548021 CFR 111.20(h)Physical plant - screening against pests
1552621 CFR 111.30(c)Equipment - automated - calibrate, inspect
1554421 CFR 111.260(d)Batch record - component; unique identifier
1555821 CFR 111.260(k)(1)Batch record - identifier; packaging
1555921 CFR 111.260(k)(1)Batch record - identifier; labels
1562521 CFR 111.180(b)(3)Documentation - components
1572321 CFR 111.365(i)Metal, foreign material
1573721 CFR 111.210(h)(5)Corrective action plans
1574421 CFR 111.210(h)(2)Master manufacturing record - sampling, tests, examinations
1574721 CFR 111.210(g)Packaging description, representative label
1576021 CFR 111.205(b)(1)Master manufacturing record-specifications; packaged, label
1579721 CFR 111.553Written procedures - product complaint
1586121 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
1597321 CFR 111.120(c)Quality control operations - material review, disposition decision
1604021 CFR 111.610(a)Records - available; FDA