FDA Inspection
Columbia Cosmetics Manufacturing, Inc.Columbia Cosmetics Manufacturing, Inc. – FDA Inspection, Apr 14, 2025
Record Details
This FDA Inspection record concerns Columbia Cosmetics Manufacturing, Inc., with an inspection on April 14, 2025, issued by the San Francisco District Office, covering human drugs.
View Company Profile
ID · 43025fef-2fca-42b6-af8b-5427a8f7e33f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1262182
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Columbia Cosmetics Manufacturing, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 29, 2020 | VAI | Center for Drug Evaluation and Research | 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 |
Other documents for Columbia Cosmetics Manufacturing, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.