Form 483

Shining Sea Fish Co. LLC Form 483, 2014-10-23

FDA issued a Form 483 to Shining Sea Fish Co. LLC on 2014-10-23 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Shining Sea Fish Co. LLC · Detroit, United States · Issued October 23, 2014

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

23 Oct 2014
21 CFR 123.6(b)

HACCP plan implementation

Cited by Marlon K Turner

23 Oct 2014
21 CFR 123.6(d)

Signed and dated

Cited by Marlon K Turner

23 Oct 2014
21 CFR 123.8(a)(2)(ii)

Calibration - adequacy

Cited by Marlon K Turner

23 Oct 2014
21 CFR 123.12(a)(2)

Importer verification

Cited by Marlon K Turner

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 123.12(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)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