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1165331

Unipack LLC — FEI 3008275696

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 25, 2022
Fiscal Year
2022
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))
  • 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))
  • 876932 (VAI Thu May 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
117721 CFR 211.63Equipment Design, Size and Location
181021 CFR 211.160(a)Lab controls established, including changes
184421 CFR 211.84(d)(2)Establish reliability of supplier's C of A
189021 CFR 211.165(e)Test methods
201421 CFR 211.188(b)(2)Identification of Equipment and Lines
202321 CFR 211.188(b)(11)Identification of Persons Performing Significant Steps
435021 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
440221 CFR 211.192Written record of investigation incomplete