Form 483

Barlean's Fishery Inc Form 483, 2010-06-25

FDA issued a Form 483 to Barlean's Fishery Inc on 2010-06-25 with 5 public-safe observations.

483· Form 483 issued5 observations

Barlean's Fishery Inc · Ferndale, United States · Issued June 25, 2010

Overview

  • 5 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.

25 Jun 2010
21 CFR 123.6(a)

Hazard analysis

Cited by James S Cartwright

25 Jun 2010
21 CFR 123.6(b)

HACCP plan implementation

Cited by James S Cartwright

25 Jun 2010
21 CFR 123.6(c)(3)

Critical limits

Cited by James S Cartwright

25 Jun 2010
21 CFR 123.7(a)

Corrective action per predetermined plan

Cited by James S Cartwright

25 Jun 2010
21 CFR 123.8(a)(1)

Reassessment of HACCP plan

Cited by James S Cartwright

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(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)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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