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1032468

Acino Products, LLC — FEI 3004723334

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 14, 2017
Fiscal Year
2018
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))
  • 1248550 (OAI Fri Aug 30 2024 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
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
360221 CFR 211.160(a)Deviations from laboratory control requirements
360321 CFR 211.160(b)Scientifically sound laboratory controls
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
440521 CFR 211.194(a)(2)Statement of methods and data