Form 483

La Michoacana, Inc. Form 483, 2018-09-05

FDA issued a Form 483 to La Michoacana, Inc. on 2018-09-05 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

La Michoacana, Inc. · Detroit, United States · Issued September 5, 2018

Overview

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

Inspectional observations

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

5 Sep 2018
21 CFR 117.126(a)(2)

Food Safety Plan - Preparation

Cited by Lauren E Sexton, Kathryn A Guardiola, Margaret N Klug, Kathryn A Cutajar

5 Sep 2018
21 CFR 117.126(a)(2)

Food Safety Plan - Preparation

Cited by Lauren E Sexton, Kathryn A Guardiola, Margaret N Klug, Kathryn A Cutajar

5 Sep 2018
21 CFR 117.135(a)(1)

Preventive Controls - Identify

Cited by Lauren E Sexton, Kathryn A Guardiola, Margaret N Klug, Kathryn A Cutajar

5 Sep 2018
21 CFR 117.135(a)(1)

Preventive Controls - Identify

Cited by Lauren E Sexton, Kathryn A Guardiola, Margaret N Klug, Kathryn A Cutajar

5 Sep 2018
21 CFR 117.35(a)

Sanitary Operations - Plant Sanitation

Cited by Lauren E Sexton, Kathryn A Guardiola, Margaret N Klug, Kathryn A Cutajar

Inspected site

LMLa Michoacana, Inc.Detroit, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.126(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 117.135(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.35(a)Cited across public-safe Form 483 observations2x
21 CFR 117.35(c)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 observations

Every observation in full, 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