Form 483

Hillcrest Bakery, Inc. Form 483, 2012-02-14

FDA issued a Form 483 to Hillcrest Bakery, Inc. on 2012-02-14 with 7 public-safe observations.

483· Form 483 issued7 observations

Hillcrest Bakery, Inc. · Bothell, United States · Issued February 14, 2012

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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.

14 Feb 2012
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Paul M Kawamoto

14 Feb 2012
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Paul M Kawamoto

14 Feb 2012
21 CFR 110.35(d)(3)

Non-food-contact surfaces (S)

Cited by Paul M Kawamoto

14 Feb 2012
21 CFR 110.80

Reasonable precautions

Cited by Paul M Kawamoto

14 Feb 2012
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Paul M Kawamoto

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 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(8)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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