Form 483

Sushi On a Roll, Inc Form 483, 2013-08-08

FDA issued a Form 483 to Sushi On a Roll, Inc on 2013-08-08 with 12 public-safe observations.

483· Form 483 issuedFoods & Cosmetics12 observations

Sushi On a Roll, Inc · San Diego, United States · Issued August 8, 2013

Overview

  • 12 public-safe observations are available for this inspection.
  • 10 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.

8 Aug 2013
21 CFR 110.35(d)(5)

Shown to be effective

Cited by Sara J Dent Acosta

8 Aug 2013
21 CFR 123.6(b)

HACCP plan implementation

Cited by Sara J Dent Acosta

8 Aug 2013
21 CFR 123.6(b)

HACCP plan location

Cited by Sara J Dent Acosta

8 Aug 2013
21 CFR 123.6(b)

No HACCP plan

Cited by Sara J Dent Acosta

8 Aug 2013
21 CFR 123.6(c)(2)

Critical control points

Cited by Sara J Dent Acosta

Inspected site

SOSushi On a Roll, IncSan Diego, 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 observations3x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
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)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)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 12 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