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1164257

Diamond Wipes International Inc. — FEI 1000069268

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 3, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bucyrus, OH (United States)

Facility

Other inspections at this facility

  • 1017373 (VAI Wed Aug 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 770122 (NAI Wed Feb 29 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 653014 (VAI Mon Mar 22 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
135821 CFR 211.100(b)SOPs not followed / documented
202821 CFR 211.192Extent of discrepancy, failure investigations
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
358521 CFR 211.110(a)Control procedures to monitor and validate performance
359221 CFR 211.110(c)In-process materials characteristics testing
360321 CFR 211.160(b)Scientifically sound laboratory controls