FDA Inspection
Columbia Cosmetics Manufacturing, Inc.Columbia Cosmetics Manufacturing, Inc. – FDA Inspection, Mar 27, 2015
Record Details
This FDA Inspection record concerns Columbia Cosmetics Manufacturing, Inc., with an inspection on March 27, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 27, 2015
- Product Type
- Drugs
View Company Profile
ID · f0d0d2b9-5656-4ab4-a5b6-32fe43355cfe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 920007
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.101(b)Identification of new containers
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.89Quarantine of Rejected Components et. al.
Showing 10 of 15 citations.
Full citation text and observation details available on the Dashboard.
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 |
| January 11, 2017 | 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.