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1272867

Grant Industries, Inc. — FEI 3009862165

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 16, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Elmwood Park, NJ (United States)

Facility

Other inspections at this facility

  • 1128499 (VAI Fri Aug 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 934195 (VAI Wed Jul 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 857375 (VAI Mon Dec 09 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
184221 CFR 211.84(d)(1)Component identity verification
192021 CFR 211.166(a)(3)Valid stability test methods
203321 CFR 211.194(c)Testing and standardization of standards et. al.