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712890

Grato Holdings, Inc. — FEI 1931484

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 25, 2011
Fiscal Year
2011
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))
  • 1111988 (OAI Fri Dec 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
122721 CFR 211.67(c)Cleaning/maintenance records not kept
136121 CFR 211.100(a)Absence of Written Procedures
202821 CFR 211.192Extent of discrepancy, failure investigations
242021 CFR 211.198(a)Quality Control Review
430721 CFR 211.80(d)Status of Each Lot Identified
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
431721 CFR 211.84(d)(3)Certificates of Testing (Containers, Closures)
433021 CFR 211.130(e)Packaging line inspection documentation
437821 CFR 211.188(b)(2)Identity of major equipment and lines used