Columbia Cosmetics Manufacturing, Inc.
Form 483 issued April 14, 2025 · San Leandro, California
- Inspection
- Apr 7 – Apr 14, 2025
- Investigators
- Anney Lin· Nathan E. Hellman
- Observations
- 6
- Pages
- 8
- FEI number
- 2919184
In short: On April 14, 2025, FDA issued a Form 483 with 6 observations to Columbia Cosmetics Manufacturing, Inc. in San Leandro, California (FEI 2919184) after an inspection that ran Apr 7 – Apr 14, 2025. The investigators were Anney Lin and Nathan E. Hellman. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Drug products failing to meet established standards, specifications and quality control…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
This inspection in context
Anney Lin
9 documents · 2023–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmColumbia Cosmetics Manufacturing, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Columbia Cosmetics Manufacturing, Inc.?
FDA listed 6 observations on this Form 483, mostly about materials, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Columbia Cosmetics Manufacturing, Inc.?
Anney Lin and Nathan E. Hellman are named on this Form 483, for the inspection of Apr 7 – Apr 14, 2025. Each investigator has a profile showing what they cite most.
When was Columbia Cosmetics Manufacturing, Inc. inspected by FDA?
The inspection ran Apr 7 – Apr 14, 2025, and the Form 483 is dated April 14, 2025.
How do I get the full Form 483 for Columbia Cosmetics Manufacturing, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.