Form 483

MAZZONE PASTA, LLC Form 483, 2010-06-10

FDA issued a Form 483 to MAZZONE PASTA, LLC on 2010-06-10 with 10 public-safe observations.

483· Form 483 issued10 observations

MAZZONE PASTA, LLC · Bloomingdale, United States · Issued June 10, 2010

Overview

  • 10 public-safe observations are available for this inspection.
  • 10 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.

10 Jun 2010
21 CFR 110.37(f)

Odor, attractant for pests, harborage

Cited by Susan W Ciani

10 Jun 2010
21 CFR 110.40(a)

Materials and workmanship

Cited by Susan W Ciani

10 Jun 2010
21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by Susan W Ciani

10 Jun 2010
21 CFR 123.6(c)(2)

Critical control points

Cited by Susan W Ciani

10 Jun 2010
21 CFR 123.6(c)(3)

Critical limits

Cited by Susan W Ciani

Inspected site

MPMAZZONE PASTA, LLCBloomingdale, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.37(f)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)(iii)Cited across public-safe Form 483 observations1x
21 CFR 123.9(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 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