FDA-Inspected Site

Dalex Enterprises Inc. dba Cruz Bakery

8 FDA inspections are on record for Dalex Enterprises Inc. dba Cruz Bakery in Hialeah, United States.

483· Form 483 issued

Hialeah, United States · Last updated August 15, 2026

Overview

  • 8 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-24.

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
15 Jun 2026 – 24 Jun 2026Foods & Cosmetics483View 483 →
25 Oct 2022 – 28 Oct 2022Foods & Cosmetics483View 483 →
19 Jun 2018 – 28 Jun 2018Foods & Cosmetics483View 483 →
15 Mar 2016 – 16 Mar 2016Foods & CosmeticsClean
23 Apr 2014 – 25 Apr 2014Foods & Cosmetics483On file
2 Feb 2011Not recorded483View 483 →
19 Mar 2010Not recorded483View 483 →
19 Feb 2009Not recorded483View 483 →

Observations on record

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

24 Jun 2026
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by Marc Balzarini, Jose E Pacheco-Rivera

24 Jun 2026
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by Marc Balzarini, Jose E Pacheco-Rivera

24 Jun 2026
21 CFR 117.135(a)(1)

Allergen preventive controls - Identify (Written)

Cited by Marc Balzarini, Jose E Pacheco-Rivera

24 Jun 2026
21 CFR 117.135(a)(1)

Allergen preventive controls - Identify (Written)

Cited by Marc Balzarini, Jose E Pacheco-Rivera

28 Oct 2022
21 CFR 117.10

Personnel

Cited by Angela F Orozco, Brian M Carril

Investigators

FDA investigators tied to this site in the record.

State Agency1 insp.
James T O Neal1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations6x
21 CFR 110.35(a)Cited across public-safe Form 483 observations6x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations5x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations5x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations4x
21 CFR 110.80(b)(3)Cited across public-safe Form 483 observations4x
21 CFR 110.10(b)(2)Cited across public-safe Form 483 observations3x
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 110.20(b)(6)Cited across public-safe Form 483 observations3x
21 CFR 110.35(c)Cited across public-safe Form 483 observations3x
21 CFR 110.35(d)Cited across public-safe Form 483 observations3x
21 CFR 110.40(a)Cited across public-safe Form 483 observations3x
21 CFR 110.80Cited across public-safe Form 483 observations3x
21 CFR 110.35(d)(3)Cited across public-safe Form 483 observations2x
21 CFR 110.37(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 110.37(d)(3)Cited across public-safe Form 483 observations2x
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.135(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 117.10Cited across public-safe Form 483 observations1x
21 CFR 117.20(b)Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 117.35(d)Cited across public-safe Form 483 observations1x
21 CFR 117.80(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 117.80(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Dalex Enterprises Inc. dba Cruz Bakery's 7 Form 483s

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