Form 483

Fortune Food Product, Inc. Form 483, 2018-02-01

FDA issued a Form 483 to Fortune Food Product, Inc. on 2018-02-01 with 15 public-safe observations.

483· Form 483 issuedFoods & Cosmetics15 observations

Fortune Food Product, Inc. · Chicago, United States · Issued February 1, 2018

Overview

  • 15 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.

1 Feb 2018
21 CFR 110.10(b)(6)

Failure to wear

Cited by Pablo Alcantara, Ana E Morales, Stefen D Mcmillan

1 Feb 2018
21 CFR 110.20(b)(1)

Sufficient space

Cited by Pablo Alcantara, Ana E Morales, Stefen D Mcmillan

1 Feb 2018
21 CFR 110.20(b)(6)

Fans/air blowing equipment

Cited by Pablo Alcantara, Ana E Morales, Stefen D Mcmillan

1 Feb 2018
21 CFR 110.35(a)

Buildings/sanitary

Cited by Pablo Alcantara, Ana E Morales, Stefen D Mcmillan

1 Feb 2018
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Pablo Alcantara, Ana E Morales, Stefen D Mcmillan

Inspected site

FFFortune Food Product, Inc.Chicago, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 112.113Cited across public-safe Form 483 observations1x
21 CFR 112.123(a)Cited across public-safe Form 483 observations1x
21 CFR 112.142(a)Cited across public-safe Form 483 observations1x
21 CFR 112.142(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 112.144(a)Cited across public-safe Form 483 observations1x
21 CFR 112.147(a)Cited across public-safe Form 483 observations1x
21 CFR 112.21(a)Cited across public-safe Form 483 observations1x
21 CFR 112.42(b)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