684166

AJES Pharmaceuticals, LLC — FEI 3001848656

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 4, 2010
Fiscal Year
2011
Product Type
Food/Cosmetics
Project Area
Food Composition, Standards, Labeling and Econ
Location
Copiague, NY (United States)

Citations

IDCFRDescription
1549221 CFR 111.25(a)Procedures - calibrating instruments
1553221 CFR 111.255(b)Batch record - complete
1558221 CFR 111.155(e)Components - contamination, deterioration, mix-ups
1571021 CFR 111.325(b)(2)(i)Document; laboratory methodology followed
1573721 CFR 111.210(h)(5)Corrective action plans
1574421 CFR 111.210(h)(2)Master manufacturing record - sampling, tests, examinations
1607121 CFR 111.35(b)(3)Documentation - instruments, controls; calibrations