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1152257

W.S. Badger Company, Inc. — FEI 3009946959

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 14, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gilsum, NH (United States)

Facility

Other inspections at this facility

  • 1206814 (OAI Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1091095 (OAI Tue May 28 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
136121 CFR 211.100(a)Absence of Written Procedures
181021 CFR 211.160(a)Lab controls established, including changes
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations
439121 CFR 211.180(e)(2)Items to cover on annual reviews