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923526

K.C. Pharmaceuticals, Inc — FEI 2026940

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 19, 2015
Fiscal Year
2015
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))
  • 1032267 (VAI Thu Nov 16 2017 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
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
145121 CFR 211.113(b)Procedures for sterile drug products
150521 CFR 211.122(d)Label storage access limited to authorized personnel
364021 CFR 211.204Returned drug products identified and held
434221 CFR 211.142(b)Storage under appropriate conditions
440221 CFR 211.192Written record of investigation incomplete