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1206814

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

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 1, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gilsum, NH (United States)

Facility

Other inspections at this facility

  • 1152257 (OAI Tue Sep 14 2021 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
145021 CFR 211.113(a)Procedures for non-sterile drug products
180921 CFR 211.160(a)Following/documenting laboratory controls
192021 CFR 211.166(a)(3)Valid stability test methods
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
202721 CFR 211.192Investigations of discrepancies, failures
2129521 CFR 211.110(b)In-process conformity - examination, sample testing
360321 CFR 211.160(b)Scientifically sound laboratory controls
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
439121 CFR 211.180(e)(2)Items to cover on annual reviews