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1247201

K.C. Pharmaceuticals, Inc — FEI 2026940

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 28, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Pomona, CA (United States)

Facility

Other inspections at this facility

  • 1197242 (OAI Mon Feb 13 2023 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
136121 CFR 211.100(a)Absence of Written Procedures
145221 CFR 211.113(b)Validation lacking for sterile drug products
150521 CFR 211.122(d)Label storage access limited to authorized personnel
191221 CFR 211.166(a)Written program not followed
441321 CFR 211.194(a)(8)Second person sign off