Atlas

FDA-Inspected Site

Sombra Cosmetics, Inc

9 FDA inspections are on record for Sombra Cosmetics, Inc in Albuquerque, United States.

483· Form 483 issued

Albuquerque, United States · Last updated August 15, 2026

Overview

  • 9 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-08.

At a glance

Inspections

9

Form 483s

5

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 May 2026 – 8 May 2026Human Drugs483View 483 →
15 Jul 2024 – 26 Jul 2024Human DrugsWLView 483 →
22 Aug 2016 – 26 Aug 2016Medical Devices & Rad Health483View 483 →
22 Jul 2013 – 26 Jul 2013Human Drugs483View 483 →
7 Jun 2011Not recorded483View 483 →
21 Jul 2009Not recordedClean
21 Dec 2005Not recordedClean
3 Feb 2003Not recordedClean
13 Mar 2000Not recordedClean

Observations on record

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

8 May 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Nicholas L Hunt, Mercedes N Overton

8 May 2026
21 CFR 211.160(a)

Lab controls established, including changes

Cited by Nicholas L Hunt, Mercedes N Overton

8 May 2026
21 CFR 211.166(a)

Lack of written stability program

Cited by Nicholas L Hunt, Mercedes N Overton

8 May 2026
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Nicholas L Hunt, Mercedes N Overton

8 May 2026
21 CFR 211.42(c)(5)

Mfg / Processing Operations Area

Cited by Nicholas L Hunt, Mercedes N Overton

Investigators

FDA investigators tied to this site in the record.

Nicholas L Hunt1 insp.
Mercedes N Overton1 insp.
Carolina D Vasquez1 insp.
Jamie L Dion1 insp.
Edith M Gonzalez1 insp.
Isabel Y Espinosa1 insp.
Daniel J Lahar1 insp.
Alanna L Mussawwir Bias1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.166(a)Cited across public-safe Form 483 observations5x
21 CFR 211.192Cited across public-safe Form 483 observations5x
21 CFR 211.25(a)Cited across public-safe Form 483 observations5x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations4x
21 CFR 211.100(a)Cited across public-safe Form 483 observations3x
21 CFR 211.110(a)Cited across public-safe Form 483 observations3x
21 CFR 211.182Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.63Cited across public-safe Form 483 observations2x
21 CFR 211.67(b)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(7)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.87Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Sombra Cosmetics, Inc's 5 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