Atlas

Form 483

M. Cutone Mushroom Co., Inc. Form 483, 2023-07-26

FDA issued a Form 483 to M. Cutone Mushroom Co., Inc. on 2023-07-26 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

M. Cutone Mushroom Co., Inc. · Avondale, United States · Issued July 26, 2023

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

26 Jul 2023
21 CFR 117.126(a)(1)

Food safety plan

Cited by Jessica M Monteiro, Christopher L Taste

26 Jul 2023
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by Jessica M Monteiro, Christopher L Taste

Inspected site

MCM. Cutone Mushroom Co., Inc.Avondale, United States

Inspection team

JMJessica M Monteiro
CLChristopher L Taste

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.126(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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