Home / Inspections / 1131763

1131763

Unipack LLC — FEI 3008275696

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 16, 2020
Fiscal Year
2021
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))
  • 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
202621 CFR 211.192Quality control unit review of records
202721 CFR 211.192Investigations of discrepancies, failures
2129621 CFR 211.186(a)Master production and control records, batch uniformity