Form 483

Sushi Boy, Inc Form 483, 2011-12-06

FDA issued a Form 483 to Sushi Boy, Inc on 2011-12-06 with 7 public-safe observations.

483· Form 483 issued7 observations

Sushi Boy, Inc · Gardena, United States · Issued December 6, 2011

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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.

6 Dec 2011
21 CFR 123.6(b)

HACCP plan implementation

Cited by Celena Ngo

6 Dec 2011
21 CFR 123.6(c)(2)

Critical control points

Cited by Celena Ngo

6 Dec 2011
21 CFR 123.6(c)(3)

Critical limits

Cited by Celena Ngo

6 Dec 2011
21 CFR 123.7(a)

Corrective action per predetermined plan

Cited by Celena Ngo

6 Dec 2011
21 CFR 123.8(a)(2)

Ongoing verification - complaints, calibration records

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(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)(3)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)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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