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1053774

kdc/one Chatsworth, Inc. — FEI 1000519695

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 25, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chatsworth, CA (United States)

Facility

Other inspections at this facility

  • 1200721 (VAI Fri Mar 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1191646 (NAI Thu Nov 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1116865 (VAI Mon Feb 03 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1045490 (NAI Wed Feb 07 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 956731 (VAI Fri Jan 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
1786321 CFR 212.60(g)(3)Complete record of all laboratory test data
181021 CFR 211.160(a)Lab controls established, including changes
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
900121 CFR 211.22(a)Lack of quality control unit