Atlas

FDA-Inspected Site

GC America, Inc.

10 FDA inspections are on record for GC America, Inc. in Alsip, United States.

483· Form 483 issued

Alsip, United States · Last updated July 10, 2026

Overview

  • 10 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-11-07.

At a glance

Inspections

10

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
3 Nov 2025 – 7 Nov 2025Human DrugsWLOn file
19 Mar 2019 – 28 Mar 2019Medical Devices & Rad Health483View 483 →
11 Jan 2018 – 26 Feb 2018Human DrugsClean
14 Oct 2015 – 26 Oct 2015Medical Devices & Rad HealthClean
5 Jun 2014 – 6 Jun 2014Medical Devices & Rad HealthClean
21 May 2013 – 13 Jun 2013Medical Devices & Rad HealthClean
13 Jul 2012Not recordedWL
8 Feb 2010Not recordedClean
15 Feb 2008Not recordedClean
23 Jun 2000Not recordedClean

Observations on record

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

28 Mar 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jesse A Vazquez

28 Mar 2019
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Jesse A Vazquez

28 Mar 2019
21 CFR 820.40(a)

Not approved or obsolete document retrieval

Cited by Jesse A Vazquez

28 Mar 2019
21 CFR 820.50(a)(3)

Acceptable supplier records, inadequate records

Cited by Jesse A Vazquez

28 Mar 2019
21 CFR 820.70(a)

Process control procedures, Lack of or inadequate procedures

Cited by Jesse A Vazquez

Investigators

FDA investigators tied to this site in the record.

Nicole S Williams2 insp.
Ramia Brzenjy1 insp.
Jesse A Vazquez1 insp.
Brian D Nicholson1 insp.
That Q Dang1 insp.
John M Seale1 insp.
Andrew A Leboeuf1 insp.
Clotia C Abbey Mensah1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 820.40(a)Cited across public-safe Form 483 observations2x
21 CFR 820.50(a)(3)Cited across public-safe Form 483 observations2x
21 CFR 820.70(a)Cited across public-safe Form 483 observations2x
21 CFR 820.70(i)Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind GC America, Inc.'s 2 Form 483s

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