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1149278

King Bio Inc. — FEI 1053442

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 12, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Asheville, NC (United States)

Facility

Other inspections at this facility

  • 1215129 (VAI Fri Jul 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1059419 (OAI Fri Jul 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1004463 (VAI Thu Mar 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 941497 (VAI Fri Sep 04 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 900797 (NAI Wed Oct 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
117721 CFR 211.63Equipment Design, Size and Location
144821 CFR 211.111Establishment of time limitations
200321 CFR 211.184(c)Individual inventory record
356721 CFR 211.84(d)(2)Component identification test
358521 CFR 211.110(a)Control procedures to monitor and validate performance
440221 CFR 211.192Written record of investigation incomplete