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1262182

Columbia Cosmetics Manufacturing, Inc. — FEI 2919184

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 14, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Leandro, CA (United States)

Facility

Other inspections at this facility

  • 1116243 (VAI Wed Jan 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1000857 (VAI Wed Jan 11 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 920007 (VAI Fri Mar 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754798 (VAI Wed Nov 30 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 694940 (VAI Fri Dec 17 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
183321 CFR 211.84(d)(1)Identity Testing of Each Component
189121 CFR 211.165(f)Failing drug products not rejected
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
431421 CFR 211.84(d)(2)Reports of Analysis (Components)