Form 483

Star Fisheries, Inc Form 483, 2014-03-26

FDA issued a Form 483 to Star Fisheries, Inc on 2014-03-26 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Star Fisheries, Inc · Wilmington, United States · Issued March 26, 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.

26 Mar 2014
21 CFR 123.6(b)

HACCP plan implementation

Cited by Celena Ngo

26 Mar 2014
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Celena Ngo

26 Mar 2014
21 CFR 123.8(a)(3)

Verification - record review - frequency

Cited by Celena Ngo

26 Mar 2014
21 CFR 123.12(a)(2)

Importer verification

Cited by Celena Ngo

Inspected site

SFStar Fisheries, IncWilmington, 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(c)(5)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 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