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1248550

Acino Products, LLC — FEI 3004723334

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 30, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hamilton, NJ (United States)

Facility

Other inspections at this facility

  • 1270811 (OAI Wed May 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1032468 (VAI Tue Nov 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 993200 (NAI Tue Nov 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 949868 (OAI Mon Oct 26 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 911866 (OAI Wed Jan 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
107921 CFR 211.22(a)Contract drug products--lack of responsibility
110521 CFR 211.22(d)Procedures not in writing, fully followed
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
136121 CFR 211.100(a)Absence of Written Procedures
145021 CFR 211.113(a)Procedures for non-sterile drug products
183321 CFR 211.84(d)(1)Identity Testing of Each Component
191421 CFR 211.166(a)Lack of written stability program
354721 CFR 211.46(b)Equipment for Environmental Control
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
439121 CFR 211.180(e)(2)Items to cover on annual reviews