Form 483

Hillcrest Bakery, Inc. Form 483, 2009-11-18

FDA issued a Form 483 to Hillcrest Bakery, Inc. on 2009-11-18 with 11 public-safe observations.

483· Form 483 issued11 observations

Hillcrest Bakery, Inc. · Bothell, United States · Issued November 18, 2009

Overview

  • 11 public-safe observations are available for this inspection.
  • 11 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

18 Nov 2009
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Abby M Miller, Katherine L Arnold

18 Nov 2009
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Abby M Miller, Katherine L Arnold

18 Nov 2009
21 CFR 110.10(b)(6)

Failure to wear

Cited by Abby M Miller, Katherine L Arnold

18 Nov 2009
21 CFR 110.20(a)(1)

Harborage areas

Cited by Abby M Miller, Katherine L Arnold

18 Nov 2009
21 CFR 110.20(a)(3)

Drainage

Cited by Abby M Miller, Katherine L Arnold

Inspected site

HBHillcrest Bakery, Inc.Bothell, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 11 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