Form 483

Ikoma Sushi, Inc Form 483, 2012-02-02

FDA issued a Form 483 to Ikoma Sushi, Inc on 2012-02-02 with 3 public-safe observations.

483· Form 483 issued3 observations

Ikoma Sushi, Inc · Sandy, United States · Issued February 2, 2012

Overview

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

Inspectional observations

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

2 Feb 2012
21 CFR 123.6(c)(2)

Critical control points

Cited by Matthew A Johnson, Brent W Higgs

2 Feb 2012
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Matthew A Johnson, Brent W Higgs

2 Feb 2012
21 CFR 123.11(b)

Sanitation monitoring

Cited by Matthew A Johnson, Brent W Higgs

Inspected site

ISIkoma Sushi, IncSandy, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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