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1116341

K.C. Pharmaceuticals, Inc — FEI 2026940

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 30, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pomona, CA (United States)

Facility

Other inspections at this facility

  • 1247201 (VAI Wed Aug 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1197242 (OAI Mon Feb 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1032267 (VAI Thu Nov 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 923526 (VAI Thu Mar 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 881454 (NAI Fri May 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
354721 CFR 211.46(b)Equipment for Environmental Control
356221 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
357321 CFR 211.101(b)Measured components for manufacturing
358521 CFR 211.110(a)Control procedures to monitor and validate performance
440221 CFR 211.192Written record of investigation incomplete