FDA-Inspected Site

Haribo Food 2004 Inc.

6 FDA inspections are on record for Haribo Food 2004 Inc. in Hialeah, United States.

Clean· No action indicated

Hialeah, United States · Last updated July 11, 2026

Overview

  • 6 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-12-16.

At a glance

Inspections

6

Form 483s

5

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
15 Dec 2025 – 16 Dec 2025Foods & CosmeticsClean
8 Sep 2025 – 12 Sep 2025Foods & Cosmetics483View 483 →
10 Jul 2024 – 16 Aug 2024Foods & Cosmetics483View 483 →
3 Mar 2023 – 22 Mar 2023Foods & Cosmetics483View 483 →
18 Jan 2022 – 18 Mar 2022Foods & Cosmetics483View 483 →
17 Aug 2020 – 18 Aug 2020Foods & Cosmetics483View 483 →

Observations on record

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

12 Sep 2025
21 CFR 1.502(a)

Develop FSVP

Cited by Yessica Lopez-Villafane, Diana M Fuentes

12 Sep 2025
21 CFR 1.504(a)

Hazard analysis written

Cited by Yessica Lopez-Villafane, Diana M Fuentes

12 Sep 2025
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by Yessica Lopez-Villafane, Diana M Fuentes

12 Sep 2025
21 CFR 1.505(c)(2)

Reevaluate - 3 years

Cited by Yessica Lopez-Villafane, Diana M Fuentes

12 Sep 2025
21 CFR 1.506(a)(1)

Approved supplier procedures - importer established

Cited by Yessica Lopez-Villafane, Diana M Fuentes

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 1.502(a)Cited across public-safe Form 483 observations4x
21 CFR 1.504(a)Cited across public-safe Form 483 observations3x
21 CFR 1.505(a)(2)Cited across public-safe Form 483 observations3x
21 CFR 1.506(d)(1)(i)Cited across public-safe Form 483 observations3x
21 CFR 1.506(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 1.506(b)Cited across public-safe Form 483 observations2x
21 CFR 1.510(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 1.510(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 1.504(d)Cited across public-safe Form 483 observations1x
21 CFR 1.505(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(1)(ii)Cited across public-safe Form 483 observations1x
21 CFR 1.506(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.506(e)(3)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Haribo Food 2004 Inc.'s 5 Form 483s

Source PDFs 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