FDA Inspection
Columbia Cosmetics Manufacturing, Inc.Columbia Cosmetics Manufacturing, Inc. – FDA Inspection, Jan 29, 2020
Record Details
This FDA Inspection record concerns Columbia Cosmetics Manufacturing, Inc., with an inspection on January 29, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 29, 2020
- Product Type
- Drugs
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ID · 46816375-72f5-4b69-be44-b7469bd24289
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1116243
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.192No written record of investigation
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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 11, 2017 | 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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