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835302

K.C. Pharmaceuticals, Inc — FEI 2026940

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
June 10, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
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))
  • 923526 (VAI Thu Mar 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
108621 CFR 211.22(b)Adequate lab facilities not available
117721 CFR 211.63Equipment Design, Size and Location
142121 CFR 211.42(c)(10)Aseptic Processing Area
145121 CFR 211.113(b)Procedures for sterile drug products
191821 CFR 211.166(a)(2)Stability sample storage conditions described
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
431721 CFR 211.84(d)(3)Certificates of Testing (Containers, Closures)