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610579

Accupack Midwest Inc — FEI 1000122754

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 12, 2009
Fiscal Year
2009
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cincinnati, OH (United States)

Facility

Other inspections at this facility

  • 1277670 (OAI Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1231139 (OAI Tue Feb 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 980166 (VAI Fri Jun 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 803394 (VAI Thu Oct 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 746861 (VAI Fri Sep 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
191421 CFR 211.166(a)Lack of written stability program
200121 CFR 211.184(b)Component Test Records
358521 CFR 211.110(a)Control procedures to monitor and validate performance
435021 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
439121 CFR 211.180(e)(2)Items to cover on annual reviews
900121 CFR 211.22(a)Lack of quality control unit