FDA Inspection 901016 — Primarch Manufacturing, Inc.

Primarch Manufacturing, Inc. — FEI 3007578064

The FDA completed an inspection of Primarch Manufacturing, Inc. on October 24, 2014 in Vista, CA. 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
October 24, 2014
Fiscal Year
2015
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Vista, CA (United States)

Citations

IDCFRDescription
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1586221 CFR 111.75(a)(2)Appropriate tests, examinations; certificate of analysis
1586921 CFR 111.75(c)Specifications met - verify; finished batch
1597821 CFR 111.123(a)(2)Quality control operations - batch production records