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1074858

Unipack LLC — FEI 3008275696

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 18, 2018
Fiscal Year
2019
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))
  • 1003818 (NAI Thu Mar 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 876932 (VAI Thu May 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
154021 CFR 211.125(a)Strict control not exercised over labeling issued
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
434521 CFR 211.160(b)(1)Samples (various types) representative, identified properly
438221 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up