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954864

Kingdomway Health Sciences LLC — FEI 2919114

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 11, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Casa Grande, AZ (United States)

Facility

Other inspections at this facility

  • 1291556 (VAI Wed Dec 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1173395 (NAI Thu Jun 09 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1079194 (VAI Fri Jan 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 722570 (NAI Thu Apr 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 663688 (NAI Fri May 21 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
122321 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
194321 CFR 211.180(e)(1)Review of representative number of batches
203421 CFR 211.194(d)Laboratory equipment calibration records