Form 483

Dulces La Mejor, LLC Form 483, 2025-07-17

FDA issued a Form 483 to Dulces La Mejor, LLC on 2025-07-17 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Dulces La Mejor, LLC · San Antonio, United States · Issued July 17, 2025

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

17 Jul 2025
21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical

Cited by Rebeca Ulloa

17 Jul 2025
21 CFR 1.506(a)(1)

Approved supplier procedures - importer established

Cited by Rebeca Ulloa

17 Jul 2025
21 CFR 1.506(b)

Supplier verification - follow written procedures

Cited by Rebeca Ulloa

17 Jul 2025
21 CFR 1.506(d)(2)

Onsite audit

Cited by Rebeca Ulloa

17 Jul 2025
21 CFR 1.506(e)(1)

Verification activity before import, periodically

Cited by Rebeca Ulloa

Inspected site

DLDulces La Mejor, LLCSan Antonio, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.504(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.506(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.506(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.506(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.510(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere