Atlas

Form 483

Cutone Specialty Foods, Inc. Form 483, 2018-02-13

FDA issued a Form 483 to Cutone Specialty Foods, Inc. on 2018-02-13 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Cutone Specialty Foods, Inc. · Chelsea, United States · Issued February 13, 2018

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

13 Feb 2018
21 CFR 114.100(b)

Maintenance of processing and production records

Cited by Nichole B Murphy

13 Feb 2018
21 CFR 117.35(a)

Sanitary Operations - Plant Maintenance

Cited by Nichole B Murphy

13 Feb 2018
21 CFR 117.4

Training of employees and records

Cited by Nichole B Murphy

Inspected site

CSCutone Specialty Foods, Inc.Chelsea, United States

Inspection team

NBNichole B Murphy

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 114.100(b)Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.4Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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