FDA Inspection 830648 — Prostar Inc.

Prostar Inc. — FEI 3004383660

The FDA completed an inspection of Prostar Inc. on April 23, 2013 in Farmington, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 23, 2013
Fiscal Year
2013
Product Type
Food/Cosmetics
Project Area
Foodborne Biological Hazards
Location
Farmington, CT (United States)

Citations

IDCFRDescription
1574921 CFR 111.210(e)Master manufacturing record - intentional overage
1575121 CFR 111.210(d)Master manufacturing record - Supplemental Facts
1595421 CFR 111.113(a)(2)Quality control master manufacturing record; material review, disposition
1598621 CFR 111.123(b)(2)Quality control - batch, product specifications