FDA-Inspected Site

Dalex Enterprises Inc

4 FDA inspections are on record for Dalex Enterprises Inc in Hialeah, United States.

483· Form 483 issued

Hialeah, United States · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-28.

At a glance

Inspections

4

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Apr 2026 – 28 Apr 2026Foods & Cosmetics483View 483 →
23 May 2023 – 26 May 2023Foods & Cosmetics483View 483 →
13 Jul 2020 – 14 Jul 2020Foods & Cosmetics483On file
29 Apr 2015 – 4 May 2015Foods & Cosmetics483On file

Observations on record

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

28 Apr 2026
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by Sharon Giamberini, Yazmith Guzman, Brian M Carril

28 Apr 2026
21 CFR 117.135(a)(1)

Process preventive controls - Implement

Cited by Sharon Giamberini, Yazmith Guzman, Brian M Carril

26 May 2023
21 CFR 117.10

Personnel

Cited by Angela F Orozco, Brian M Carril

26 May 2023
21 CFR 117.10

Personnel

Cited by Angela F Orozco, Brian M Carril

26 May 2023
21 CFR 117.20(b)

Plant construction and design

Cited by Angela F Orozco, Brian M Carril

Investigators

FDA investigators tied to this site in the record.

State Agency1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 117.10Cited across public-safe Form 483 observations2x
21 CFR 117.20(b)Cited across public-safe Form 483 observations2x
21 CFR 117.35(a)Cited across public-safe Form 483 observations2x
21 CFR 117.35(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 117.35(c)Cited across public-safe Form 483 observations2x
21 CFR 117.35(d)Cited across public-safe Form 483 observations2x
21 CFR 117.37Cited across public-safe Form 483 observations2x
21 CFR 117.4Cited across public-safe Form 483 observations2x
21 CFR 117.40Cited across public-safe Form 483 observations2x
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.135(a)(1)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Dalex Enterprises Inc's 4 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