Form 483

Sushi Boy, Inc Form 483, 2014-01-29

FDA issued a Form 483 to Sushi Boy, Inc on 2014-01-29 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Sushi Boy, Inc · Gardena, United States · Issued January 29, 2014

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

29 Jan 2014
21 CFR 123.6(c)(3)

Critical limits

Cited by Celena Ngo

29 Jan 2014
21 CFR 123.6(d)

Signed and dated

Cited by Celena Ngo

29 Jan 2014
21 CFR 123.7(a)

Corrective action per predetermined plan

Cited by Celena Ngo

29 Jan 2014
21 CFR 123.8(a)(2)(ii)

Calibration - adequacy

Cited by Celena Ngo

29 Jan 2014
21 CFR 123.9(a)

Records - content

Cited by Celena Ngo

Inspected site

SBSushi Boy, IncGardena, 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)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations1x
21 CFR 123.9(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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