Form 483

Biondillo's Baking Company LLC Form 483, 2018-01-09

FDA issued a Form 483 to Biondillo's Baking Company LLC on 2018-01-09 with 15 public-safe observations.

483· Form 483 issuedFoods & Cosmetics15 observations

Biondillo's Baking Company LLC · Chicago, United States · Issued January 9, 2018

Overview

  • 15 public-safe observations are available for this inspection.
  • 14 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.

9 Jan 2018
21 CFR 117.20(b)

Plant Construction and Design

Cited by Jayne E Holcomb, Brian P Emanuel

9 Jan 2018
21 CFR 117.35(a)

Sanitary Operations - Plant Sanitation

Cited by Jayne E Holcomb, Brian P Emanuel

9 Jan 2018
21 CFR 117.35(e)

Sanitation of non-food contact surfaces - frequency

Cited by Jayne E Holcomb, Brian P Emanuel

9 Jan 2018
21 CFR 117.80(c)(8)

Process Control - Foreign Objects

Cited by Jayne E Holcomb, Brian P Emanuel

9 Jan 2018
21 CFR 117.80(a)

Plant Operations - precautions

Cited by Jayne E Holcomb, Brian P Emanuel

Inspected site

BBBiondillo's Baking Company LLCChicago, United States

Inspection team

BPBrian P Emanuel

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.35(a)Cited across public-safe Form 483 observations2x
21 CFR 117.10Cited across public-safe Form 483 observations1x
21 CFR 117.20(b)Cited across public-safe Form 483 observations1x
21 CFR 117.35(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 117.35(c)Cited across public-safe Form 483 observations1x
21 CFR 117.35(d)Cited across public-safe Form 483 observations1x
21 CFR 117.35(e)Cited across public-safe Form 483 observations1x
21 CFR 117.37Cited across public-safe Form 483 observations1x
21 CFR 117.40Cited across public-safe Form 483 observations1x
21 CFR 117.80(a)Cited across public-safe Form 483 observations1x
21 CFR 117.80(c)Cited across public-safe Form 483 observations1x
21 CFR 117.80(c)(8)Cited across public-safe Form 483 observations1x
21 CFR 117.80(c)(9)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 15 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