Atlas

Form 483

Chocolatera de Jalisco S.A. de C.V. Form 483, 2018-11-07

FDA issued a Form 483 to Chocolatera de Jalisco S.A. de C.V. on 2018-11-07 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Chocolatera de Jalisco S.A. de C.V. · Guadalajara, Mexico · Issued November 7, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

7 Nov 2018
21 CFR 117.80(a)

Plant Operations - precautions

Cited by Grant L Davis, Asha Dwarka

7 Nov 2018
21 CFR 117.80(a)

Plant Operations - precautions

Cited by Grant L Davis, Asha Dwarka

Inspected site

CDChocolatera de Jalisco S.A. de C.V.Guadalajara, Mexico

Inspection team

GLGrant L Davis
ADAsha Dwarka

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.80(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 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