Form 483

Star Bakery, Inc. Form 483, 2012-04-13

FDA issued a Form 483 to Star Bakery, Inc. on 2012-04-13 with 5 public-safe observations.

483· Form 483 issued5 observations

Star Bakery, Inc. · Oak Park, United States · Issued April 13, 2012

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.

13 Apr 2012
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Lauren E Burke

13 Apr 2012
21 CFR 110.10(b)(6)

Failure to wear

Cited by Lauren E Burke

13 Apr 2012
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Lauren E Burke

13 Apr 2012
21 CFR 110.80

Reasonable precautions

Cited by Lauren E Burke

13 Apr 2012
21 CFR 110.80(a)(1)

Storage

Cited by Lauren E Burke

Inspected site

SBStar Bakery, Inc.Oak Park, 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)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(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