Form 483

Barlean's Fishery Inc Form 483, 2017-12-20

FDA issued a Form 483 to Barlean's Fishery Inc on 2017-12-20 with 10 public-safe observations.

483· Form 483 issuedFoods & Cosmetics10 observations

Barlean's Fishery Inc · Ferndale, United States · Issued December 20, 2017

Overview

  • 10 public-safe observations are available for this inspection.
  • 5 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.

20 Dec 2017
21 CFR 123.6(c)(2)

Critical control points

Cited by Lisa A Bowden

20 Dec 2017
21 CFR 123.6(c)(2)

Critical control points

Cited by Lisa A Bowden

20 Dec 2017
21 CFR 123.6(c)(3)

Critical limits

Cited by Lisa A Bowden

20 Dec 2017
21 CFR 123.6(c)(3)

Critical limits

Cited by Lisa A Bowden

20 Dec 2017
21 CFR 123.6(c)(6)

Verification procedures - adequacy

Cited by Lisa A Bowden

Inspected site

BFBarlean's Fishery IncFerndale, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(7)Cited across public-safe Form 483 observations2x
21 CFR 123.8(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 10 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