Home / Inspections / 1223081

1223081

Universal Packaging Systems, Inc. — FEI 1000125370

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 17, 2023
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chino, CA (United States)

Facility

Other inspections at this facility

  • 1271195 (VAI Thu May 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1203142 (VAI Fri Mar 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062443 (NAI Wed Jul 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 953161 (VAI Tue Dec 22 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 598205 (NAI Tue Jul 21 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
141321 CFR 211.42(c)(5)Mfg / Processing Operations Area
180921 CFR 211.160(a)Following/documenting laboratory controls
202821 CFR 211.192Extent of discrepancy, failure investigations
360321 CFR 211.160(b)Scientifically sound laboratory controls