Form 483

Ikoma Sushi, Inc Form 483, 2014-12-18

FDA issued a Form 483 to Ikoma Sushi, Inc on 2014-12-18 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Ikoma Sushi, Inc · Sandy, United States · Issued December 18, 2014

Overview

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

Inspectional observations

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

18 Dec 2014
21 CFR 110.10(b)(6)

Failure to wear

Cited by William A Lanier

18 Dec 2014
21 CFR 123.6(b)

HACCP plan implementation

Cited by William A Lanier

18 Dec 2014
21 CFR 123.6(b)

HACCP plan location

Cited by William A Lanier

18 Dec 2014
21 CFR 123.11(b)

Sanitation monitoring

Cited by William A Lanier

Inspected site

ISIkoma Sushi, IncSandy, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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