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1293364

Grand River Aseptic Manufacturing, Inc. — FEI 3008716173

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 4, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Grand Rapids, MI (United States)

Facility

Other inspections at this facility

  • 1233170 (VAI Wed Feb 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1145269 (VAI Fri Jul 02 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1060743 (NAI Wed Jun 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 955644 (NAI Thu Dec 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 904415 (VAI Mon Nov 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
145221 CFR 211.113(b)Validation lacking for sterile drug products