Form 483

Biondillo's Baking Company LLC Form 483, 2014-10-17

FDA issued a Form 483 to Biondillo's Baking Company LLC on 2014-10-17 with 13 public-safe observations.

483· Form 483 issuedFoods & Cosmetics13 observations

Biondillo's Baking Company LLC · Chicago, United States · Issued October 17, 2014

Overview

  • 13 public-safe observations are available for this inspection.
  • 13 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.

17 Oct 2014
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Patrick E Gainer

17 Oct 2014
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Patrick E Gainer

17 Oct 2014
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Patrick E Gainer

17 Oct 2014
21 CFR 110.20(a)(1)

Harborage areas

Cited by Patrick E Gainer

17 Oct 2014
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Patrick E Gainer

Inspected site

BBBiondillo's Baking Company LLCChicago, 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)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.37(f)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 13 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