Form 483

Blue Heron Bakery Form 483, 2018-02-01

FDA issued a Form 483 to Blue Heron Bakery on 2018-02-01 with 12 public-safe observations.

483· Form 483 issuedFoods & Cosmetics12 observations

Blue Heron Bakery · Olympia, United States · Issued February 1, 2018

Overview

  • 12 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.

1 Feb 2018
21 CFR 110.10(b)(6)

Failure to wear

Cited by Sandra K Wangen

1 Feb 2018
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Sandra K Wangen

1 Feb 2018
21 CFR 110.20(b)(7)

Screening

Cited by Sandra K Wangen

1 Feb 2018
21 CFR 110.20(b)(7)

Screening

Cited by Sandra K Wangen

1 Feb 2018
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Sandra K Wangen

Inspected site

BHBlue Heron BakeryOlympia, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations3x
21 CFR 110.10(b)(7)Cited across public-safe Form 483 observations3x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations3x
21 CFR 110.35(c)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 12 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