1062670

Phi Sciences — FEI 3001970179

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 16, 2018
Fiscal Year
2018
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Cottonwood, AZ (United States)

Citations

IDCFRDescription
1553121 CFR 111.255(a)Batch record - every batch
1564121 CFR 111.453Written procedures - holding
1576221 CFR 111.205(a)Master manufacturing record - each batch
1579721 CFR 111.553Written procedures - product complaint
1582521 CFR 111.65Quality control - quality, dietary supplement
1582921 CFR 111.70(b)(1)Specifications - component identity
1583021 CFR 111.70(b)(2)Specifications-component purity, strength, composition
1583121 CFR 111.70(b)(3)Specifications - contamination limits
1583921 CFR 111.70(e)Specifications - identity, purity, strength, composition
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1592121 CFR 111.95(b)(2)Documentation - supplier qualification
1593921 CFR 111.105(g)Quality control - reserve samples
1604221 CFR 111.503Written procedures - returned dietary supplement