Form 483

Soojian, Inc. dba ak-mak Bakeries Form 483, 2022-02-23

FDA issued a Form 483 to Soojian, Inc. dba ak-mak Bakeries on 2022-02-23 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Soojian, Inc. dba ak-mak Bakeries · Sanger, United States · Issued February 23, 2022

Overview

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

Inspectional observations

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

23 Feb 2022
21 CFR 117.40

Equipment and utensils - Design and maintenance

Cited by Ismael Garibay, Anna L Viveros-Hernandez, Anna L Marroquin

23 Feb 2022
21 CFR 117.40

Equipment and utensils - Design and maintenance

Cited by Ismael Garibay, Anna L Viveros-Hernandez, Anna L Marroquin

23 Feb 2022
21 CFR 117.40

Equipment and utensils - Design and maintenance

Cited by Ismael Garibay, Anna L Viveros-Hernandez, Anna L Marroquin

Inspected site

SISoojian, Inc. dba ak-mak BakeriesSanger, United States

Inspection team

ALAnna L Viveros-Hernandez
ALAnna L Marroquin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.40Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 3 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