Home / Inspections / 1116243

1116243

Columbia Cosmetics Manufacturing, Inc. — FEI 2919184

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 29, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
San Leandro, CA (United States)

Facility

Other inspections at this facility

  • 1262182 (OAI Mon Apr 14 2025 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
189121 CFR 211.165(f)Failing drug products not rejected
360321 CFR 211.160(b)Scientifically sound laboratory controls
439121 CFR 211.180(e)(2)Items to cover on annual reviews
457621 CFR 211.192No written record of investigation