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1110616

Central Solutions, Inc. — FEI 1000138339

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 21, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Kansas City, KS (United States)

Facility

Other inspections at this facility

  • 1265584 (VAI Wed Apr 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1215737 (NAI Tue Aug 15 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 934709 (NAI Fri Jul 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 720736 (NAI Tue Apr 19 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 662998 (VAI Fri Apr 09 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
122321 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
136121 CFR 211.100(a)Absence of Written Procedures
180121 CFR 211.84(a)Components withheld from use pending release
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
360221 CFR 211.160(a)Deviations from laboratory control requirements
439121 CFR 211.180(e)(2)Items to cover on annual reviews
457621 CFR 211.192No written record of investigation