891224

Acino Products, LLC — FEI 3004723334

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 19, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
Location
Hamilton, NJ (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
145021 CFR 211.113(a)Procedures for non-sterile drug products
363221 CFR 211.170(b)Annual visual exams of drug products
439121 CFR 211.180(e)(2)Items to cover on annual reviews