1195684

Avlon Industries, Inc — FEI 3007090726

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 24, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Melrose Park, IL (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
183321 CFR 211.84(d)(1)Identity Testing of Each Component
191721 CFR 211.166(a)(1)Sample size - test intervals
197521 CFR 211.182Written records kept in individual logs
360321 CFR 211.160(b)Scientifically sound laboratory controls