Home / Inspections / 810508

810508

Cosmax USA, Corporation — FEI 3002679704

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 13, 2012
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Carteret, NJ (United States)

Facility

Other inspections at this facility

  • 1281580 (VAI Fri Sep 12 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1177107 (VAI Fri Jul 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1121022 (OAI Tue Mar 17 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1099676 (NAI Thu Jul 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1025842 (VAI Wed Sep 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
358521 CFR 211.110(a)Control procedures to monitor and validate performance
359221 CFR 211.110(c)In-process materials characteristics testing
359421 CFR 211.110(d)Rejected in-process materials not quarantined
430321 CFR 211.67(b)Written procedures fail to include
430521 CFR 211.68(b)Backup data not assured as exact and complete
431421 CFR 211.84(d)(2)Reports of Analysis (Components)