799177

Pristine Bay LLC — FEI 3004476935

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 17, 2012
Fiscal Year
2012
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
West Chester, OH (United States)

Citations

IDCFRDescription
15351FDCA 761(b)(1)No AE report made (dietary supplement)
1540121 CFR 111.12(b)Personnel - quality control operations; identified
1545421 CFR 111.16Written procedures - pest control
1564121 CFR 111.453Written procedures - holding
1579721 CFR 111.553Written procedures - product complaint
1580821 CFR 111.570(a)Records - product complaints: readily available
1582521 CFR 111.65Quality control - quality, dietary supplement
1583921 CFR 111.70(e)Specifications - identity, purity, strength, composition
1586921 CFR 111.75(c)Specifications met - verify; finished batch