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980166

Accupack Midwest Inc — FEI 1000122754

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 17, 2016
Fiscal Year
2016
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))
  • 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))
  • 610579 (VAI Wed Aug 12 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
163221 CFR 211.130(c)Lot or control number assigned
178721 CFR 211.80(a)Procedures To Be in Writing
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
191421 CFR 211.166(a)Lack of written stability program
358521 CFR 211.110(a)Control procedures to monitor and validate performance