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949868

Acino Products, LLC — FEI 3004723334

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 26, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
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))
  • 1248550 (OAI Fri Aug 30 2024 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))
  • 911866 (OAI Wed Jan 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
117721 CFR 211.63Equipment Design, Size and Location
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
344521 CFR 211.65(a)Equipment construction - reactive surfaces
439121 CFR 211.180(e)(2)Items to cover on annual reviews
900121 CFR 211.22(a)Lack of quality control unit