Form 483

Biondillo's Baking Company LLC Form 483, 2018-08-28

FDA issued a Form 483 to Biondillo's Baking Company LLC on 2018-08-28 with 28 public-safe observations.

483· Form 483 issuedFoods & Cosmetics28 observations

Biondillo's Baking Company LLC · Chicago, United States · Issued August 28, 2018

Overview

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

Inspectional observations

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

28 Aug 2018
21 CFR 117.10

Personnel

Cited by Audrey A De La Cruz, Jayne E Holcomb, Brian P Emanuel

28 Aug 2018
21 CFR 117.10

Personnel

Cited by Audrey A De La Cruz, Jayne E Holcomb, Brian P Emanuel

28 Aug 2018
21 CFR 117.126(a)(1)

Food Safety Plan

Cited by Audrey A De La Cruz, Jayne E Holcomb, Brian P Emanuel

28 Aug 2018
21 CFR 117.126(a)(1)

Food Safety Plan

Cited by Audrey A De La Cruz, Jayne E Holcomb, Brian P Emanuel

28 Aug 2018
21 CFR 117.20(b)

Plant Construction and Design

Cited by Audrey A De La Cruz, Jayne E Holcomb, Brian P Emanuel

Inspected site

BBBiondillo's Baking Company LLCChicago, United States

Inspection team

AAAudrey A De La Cruz
BPBrian P Emanuel

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.10Cited across public-safe Form 483 observations2x
21 CFR 117.126(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.20(b)Cited across public-safe Form 483 observations2x
21 CFR 117.35(a)Cited across public-safe Form 483 observations2x
21 CFR 117.35(c)Cited across public-safe Form 483 observations2x
21 CFR 117.35(e)Cited across public-safe Form 483 observations2x
21 CFR 117.37Cited across public-safe Form 483 observations2x
21 CFR 117.4Cited across public-safe Form 483 observations2x
21 CFR 117.40Cited across public-safe Form 483 observations2x
21 CFR 117.80(a)Cited across public-safe Form 483 observations2x
21 CFR 117.80(b)(8)Cited across public-safe Form 483 observations2x
21 CFR 117.80(c)Cited across public-safe Form 483 observations2x
21 CFR 117.80(c)(8)Cited across public-safe Form 483 observations2x
21 CFR 117.80(c)(9)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 28 observations

The full inspection record, as Atlas holds it, 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