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1044788

Alcami Corporation — FEI 2210008

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 19, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Edison, NJ (United States)

Facility

Other inspections at this facility

  • 1115853 (NAI Wed Dec 18 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1018965 (NAI Fri May 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 989639 (VAI Tue Aug 23 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 941628 (VAI Wed Aug 26 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 884996 (OAI Thu Jul 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
240121 CFR 211.194(a)(4)Complete Test Data
435021 CFR 211.160(b)(3)Drug products-sampling procedures/specifications