Atlas

FDA-Inspected Site

Combe Products, Inc.

10 FDA inspections are on record for Combe Products, Inc. in Naguabo, United States.

483· Form 483 issued

Naguabo, United States · Last updated August 15, 2026

Overview

  • 10 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-11-06.

At a glance

Inspections

10

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
3 Nov 2025 – 6 Nov 2025Human Drugs483View 483 →
21 Oct 2024 – 24 Oct 2024Medical Devices & Rad HealthClean
26 Apr 2021 – 30 Apr 2021Human DrugsClean
16 Aug 2016 – 22 Aug 2016Human DrugsClean
26 Aug 2014 – 5 Sep 2014Human Drugs483View 483 →
23 Sep 2011Not recorded483View 483 →
30 Nov 2009Not recorded483View 483 →
8 Jun 2007Not recordedClean
23 Jun 2005Not recordedClean
14 Jan 2003Not recordedClean

Observations on record

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

6 Nov 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Jose F Velez

5 Sep 2014
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Libia M Lugo

23 Sep 2011
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Viviana Matta

23 Sep 2011
21 CFR 211.180(e)(2)

Items to cover on annual reviews

Cited by Viviana Matta

30 Nov 2009
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Jorge L Lajara

Investigators

FDA investigators tied to this site in the record.

Ariel Cruz Figueroa2 insp.
Jose F Velez1 insp.
Monica C Burgos Garcia1 insp.
Libia M Lugo1 insp.
Viviana Matta1 insp.
Jorge L Lajara1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Combe Products, Inc.'s 4 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