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671891

Cosmax USA, Corporation — FEI 3002679704

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 19, 2010
Fiscal Year
2010
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
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
135821 CFR 211.100(b)SOPs not followed / documented
202621 CFR 211.192Quality control unit review of records
202721 CFR 211.192Investigations of discrepancies, failures
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified