Atlas

Form 483

Simon Brothers Bakery, Inc. Form 483, 2011-04-13

FDA issued a Form 483 to Simon Brothers Bakery, Inc. on 2011-04-13 with 3 public-safe observations.

483· Form 483 issued3 observations

Simon Brothers Bakery, Inc. · Skokie, United States · Issued April 13, 2011

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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 2011
21 CFR 110.35(a)

Buildings/good repair

Cited by Kristen E Szenderski

13 Apr 2011
21 CFR 110.80(a)(1)

Storage

Cited by Kristen E Szenderski

13 Apr 2011
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Kristen E Szenderski

Inspected site

SBSimon Brothers Bakery, Inc.Skokie, United States

Inspection team

KEKristen E Szenderski

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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