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1197242

K.C. Pharmaceuticals, Inc — FEI 2026940

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 13, 2023
Fiscal Year
2023
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))
  • 1116341 (VAI Thu Jan 30 2020 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
143521 CFR 211.42(c)(10)(v)Cleaning System
145221 CFR 211.113(b)Validation lacking for sterile drug products
189021 CFR 211.165(e)Test methods
241921 CFR 211.198(a)Complaint Handling Procedure
354721 CFR 211.46(b)Equipment for Environmental Control
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
441321 CFR 211.194(a)(8)Second person sign off