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1111988

Grato Holdings, Inc. — FEI 1931484

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 6, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Woodbine, IA (United States)

Facility

Other inspections at this facility

  • 1301428 (NAI Tue Feb 03 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1282396 (VAI Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1175267 (VAI Thu Jul 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1146470 (VAI Wed Jul 14 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1044327 (VAI Fri Mar 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
180221 CFR 211.84(b)Representative Samples
188321 CFR 211.165(a)Testing and release for distribution
189021 CFR 211.165(e)Test methods
203221 CFR 211.194(b)Test method modification records not maintained