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1014993

Diamond Wipes International, Inc. — FEI 3003887639

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 17, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chino, CA (United States)

Facility

Other inspections at this facility

  • 1278985 (VAI Fri Oct 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1136946 (VAI Fri Mar 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1101651 (VAI Fri Sep 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1086839 (VAI Fri Apr 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 947970 (OAI Mon Nov 02 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
189121 CFR 211.165(f)Failing drug products not rejected
202621 CFR 211.192Quality control unit review of records
202721 CFR 211.192Investigations of discrepancies, failures
240121 CFR 211.194(a)(4)Complete Test Data
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
360221 CFR 211.160(a)Deviations from laboratory control requirements
360321 CFR 211.160(b)Scientifically sound laboratory controls
431421 CFR 211.84(d)(2)Reports of Analysis (Components)