Atlas

FDA-Inspected Site

Columbia Cosmetics Manufacturing, Inc.

8 FDA inspections are on record for Columbia Cosmetics Manufacturing, Inc. in San Leandro, United States.

483· Form 483 issued

San Leandro, United States · Last updated July 10, 2026

Overview

  • 8 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-04-14.

At a glance

Inspections

8

Form 483s

7

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
7 Apr 2025 – 14 Apr 2025Human DrugsWLView 483 →
23 Jan 2020 – 29 Jan 2020Human Drugs483View 483 →
5 Jan 2017 – 11 Jan 2017Human Drugs483View 483 →
5 Mar 2015 – 27 Mar 2015Human Drugs483View 483 →
30 Nov 2011Not recorded483On file
17 Dec 2010Not recorded483On file
29 Jul 2008Not recorded483On file
14 Nov 2003Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

14 Apr 2025
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Anney Lin, Nathan E Hellman

14 Apr 2025
21 CFR 211.165(f)

Failing drug products not rejected

Cited by Anney Lin, Nathan E Hellman

14 Apr 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Anney Lin, Nathan E Hellman

14 Apr 2025
21 CFR 211.67(b)(3)

Cleaning SOPs/instructions

Cited by Anney Lin, Nathan E Hellman

14 Apr 2025
21 CFR 211.84(d)(1)

Identity Testing of Each Component

Cited by Anney Lin, Nathan E Hellman

Investigators

FDA investigators tied to this site in the record.

Kevin P Foley2 insp.
Anney Lin1 insp.
Nathan E Hellman1 insp.
Scott N Lim1 insp.
David Eng1 insp.
James C Lee1 insp.
Lucila B Nwatu1 insp.
Stephanie A Slater1 insp.
Daniel J Roberts1 insp.
Mei-Chiung J Huang1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations4x
21 CFR 211.160(b)Cited across public-safe Form 483 observations4x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations3x
21 CFR 211.67(b)Cited across public-safe Form 483 observations3x
21 CFR 211.68(a)Cited across public-safe Form 483 observations3x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations3x
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.101(b)Cited across public-safe Form 483 observations2x
21 CFR 211.125(f)Cited across public-safe Form 483 observations2x
21 CFR 211.165(f)Cited across public-safe Form 483 observations2x
21 CFR 211.188Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.198(a)Cited across public-safe Form 483 observations2x
21 CFR 211.22(a)Cited across public-safe Form 483 observations2x
21 CFR 211.25(a)Cited across public-safe Form 483 observations2x
21 CFR 211.67(b)(3)Cited across public-safe Form 483 observations2x
21 CFR 211.89Cited across public-safe Form 483 observations2x
FDCA 601(c)Cited across public-safe Form 483 observations2x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Columbia Cosmetics Manufacturing, Inc.'s 7 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat