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876932

Unipack LLC — FEI 3008275696

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 1, 2014
Fiscal Year
2014
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
189021 CFR 211.165(e)Test methods
360321 CFR 211.160(b)Scientifically sound laboratory controls
363221 CFR 211.170(b)Annual visual exams of drug products
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
438921 CFR 211.198(a)Procedures to be written and followed