Form 483

El Gordo Spices, LLC Form 483, 2019-08-30

FDA issued a Form 483 to El Gordo Spices, LLC on 2019-08-30 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

El Gordo Spices, LLC · Dallas, United States · Issued August 30, 2019

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

30 Aug 2019
21 CFR 117.10

Personnel

Cited by Brandi E Williams, Liza L Quiles, Tuan A Nguyen

30 Aug 2019
21 CFR 117.35(a)

Sanitary Operations - Plant Sanitation

Cited by Brandi E Williams, Liza L Quiles, Tuan A Nguyen

30 Aug 2019
21 CFR 117.80(a)(2)

Appropriate quality control operations

Cited by Brandi E Williams, Liza L Quiles, Tuan A Nguyen

30 Aug 2019
21 CFR 123.6(b)

No HACCP plan

Cited by Brandi E Williams, Liza L Quiles, Tuan A Nguyen

Inspected site

EGEl Gordo Spices, LLCDallas, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.10Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.80(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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