Form 483

Shining Sea Fish Co. LLC Form 483, 2011-09-30

FDA issued a Form 483 to Shining Sea Fish Co. LLC on 2011-09-30 with 9 public-safe observations.

483· Form 483 issued9 observations

Shining Sea Fish Co. LLC · Detroit, United States · Issued September 30, 2011

Overview

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

Inspectional observations

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

30 Sep 2011
21 CFR 123.6(a)

Hazard analysis

Cited by Rasha Bamieh, Tracey L Siebesma, Sarah M Napier

30 Sep 2011
21 CFR 123.6(b)

No HACCP plan

Cited by Rasha Bamieh, Tracey L Siebesma, Sarah M Napier

30 Sep 2011
21 CFR 123.6(c)(1)

Food safety hazards

Cited by Rasha Bamieh, Tracey L Siebesma, Sarah M Napier

30 Sep 2011
21 CFR 123.6(c)(3)

Critical limits

Cited by Rasha Bamieh, Tracey L Siebesma, Sarah M Napier

30 Sep 2011
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Rasha Bamieh, Tracey L Siebesma, Sarah M Napier

Inspected site

SSShining Sea Fish Co. LLCDetroit, 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 123.16Cited across public-safe Form 483 observations1x
21 CFR 123.6(a)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(1)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)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 9 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