888236

AJES Pharmaceuticals, LLC — FEI 3001848656

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 18, 2014
Fiscal Year
2014
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Copiague, NY (United States)

Citations

IDCFRDescription
15351FDCA 761(b)(1)No AE report made (dietary supplement)
1556721 CFR 111.260(l)(4)Batch record - approved, released, rejected
1570221 CFR 111.320(b)Examination, testing; scientifically valid
1573421 CFR 111.360Manufacturing operations - sanitation
1580021 CFR 111.560(a)(2)Product complaint - quality control investigate
1585321 CFR 111.73Specifications met - identity, purity, strength, composition
1585821 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
1607221 CFR 111.35(b)(3)Instruments, controls; calibrate date, reference std, method