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1121149

HNC Products Inc. — FEI 3000205427

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 17, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Clinton, IL (United States)

Facility

Other inspections at this facility

  • 1149849 (VAI Tue Aug 24 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 697074 (NAI Tue Nov 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 611879 (VAI Fri Sep 11 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
197521 CFR 211.182Written records kept in individual logs
200821 CFR 211.186(a)Written procedures followed
200921 CFR 211.188Prepared for each batch, include complete information
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
900121 CFR 211.22(a)Lack of quality control unit