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704289

Unipack LLC — FEI 3008275696

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 8, 2010
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
South Plainfield, NJ (United States)

Facility

Other inspections at this facility

  • 1274451 (OAI Mon Jun 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1165331 (OAI Fri Mar 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1131763 (OAI Fri Oct 16 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1074858 (OAI Tue Dec 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1003818 (NAI Thu Mar 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
197621 CFR 211.182Specific information required in individual logs
358521 CFR 211.110(a)Control procedures to monitor and validate performance
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
432521 CFR 211.110(a)Control procedures fail to include the following