FDA Inspection
Columbia Cosmetics Manufacturing, Inc.Columbia Cosmetics Manufacturing, Inc. – FDA Inspection, Jan 11, 2017
Record Details
This FDA Inspection record concerns Columbia Cosmetics Manufacturing, Inc., with an inspection on January 11, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- David Eng (Issuing Officer)
- James C. Lee (Issuing Officer)
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ID · ca1855b6-a612-4ee4-b9ae-a6061f6e86d0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000857
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Columbia Cosmetics Manufacturing, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 14, 2025 | OAI | San Francisco District Office | Drug Quality Assurance |
| January 29, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 27, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 30, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 17, 2010 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
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