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1032267

K.C. Pharmaceuticals, Inc — FEI 2026940

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 16, 2017
Fiscal Year
2018
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))
  • 1116341 (VAI Thu Jan 30 2020 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
126321 CFR 211.68(b)Computer control of master formula records
145121 CFR 211.113(b)Procedures for sterile drug products
181021 CFR 211.160(a)Lab controls established, including changes
187621 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
203121 CFR 211.194(a)Complete test data included in records