Columbia Cosmetics Manufacturing, Inc.
FDA inspection history in San Leandro, California, 2020 to 2025
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2020: one Form 483; 2025: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at San Leandro, California.
- 2025One warning letter and one Form 483, at San Leandro, California.
- 2025The longest 483 on file: 6 observations over 8 pages at San Leandro, California.
Cited most
Across all Columbia Cosmetics Manufacturing observations on file
- 21 CFR 211.165(f)Testing and release for distribution2
- 21 CFR 211.192Production record review2
- 21 CFR 211.67(b)(3)Equipment cleaning and maintenance2
- 21 CFR 211.84(d)(1)Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
The complete Columbia Cosmetics Manufacturing file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
San Leandro, California
Two Form 483s and one warning letter · 2020 to 2025 · 11 observations
Latest: Warning letter, Sep 11, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-11 | Warning letter Warning letter | San Leandro, California | — | $99 |
| 2025-04-14 | 483 Form 483 | San Leandro, California | 6 | $99 |
| 2020-01-29 | 483 Form 483 | San Leandro, California | 5 | $99 |
Investigators on these documents
FEI number 2919184 · most recent document Sep 11, 2025
About Columbia Cosmetics Manufacturing, Inc.
How many FDA Form 483s has Columbia Cosmetics Manufacturing, Inc. received?
FDA Intel has 2 Form 483s on file for Columbia Cosmetics Manufacturing, Inc.; the most recent is dated Apr 14, 2025.
When was Columbia Cosmetics Manufacturing, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Columbia Cosmetics Manufacturing, Inc. is a Form 483 dated Apr 14, 2025, for the site in San Leandro, California.
What did FDA cite at Columbia Cosmetics Manufacturing, Inc.?
The regulations cited most in the observations on file for Columbia Cosmetics Manufacturing, Inc. are 21 CFR 211.165(f) (Testing and release for distribution), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.67(b)(3) (Equipment cleaning and maintenance), 2 times.
Has Columbia Cosmetics Manufacturing, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Columbia Cosmetics Manufacturing, Inc.; the most recent is dated Sep 11, 2025.