962200

AJES Pharmaceuticals, LLC — FEI 3001848656

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 9, 2016
Fiscal Year
2016
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Copiague, NY (United States)

Citations

IDCFRDescription
15352FDCA 761(b)(1)No label copy submitted with AE report (dietary supplement)
1546921 CFR 111.20(c)(3)Physical plant - separate areas for products
1585321 CFR 111.73Specifications met - identity, purity, strength, composition
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1590121 CFR 111.83(b)(3)Reserve sample - retained
1603721 CFR 111.605Records - keep: 1 year, 2 years