Atlas

Form 483

Cutone Specialty Foods, Inc. Form 483, 2012-01-20

FDA issued a Form 483 to Cutone Specialty Foods, Inc. on 2012-01-20 with 4 public-safe observations.

483· Form 483 issued4 observations

Cutone Specialty Foods, Inc. · Chelsea, United States · Issued January 20, 2012

Overview

  • 4 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.

20 Jan 2012
21 CFR 108.25(c)(3)(ii)

Process information availability

Cited by Mark E Farrell

20 Jan 2012
21 CFR 114.80(a)(4)

Container testing

Cited by Mark E Farrell

20 Jan 2012
21 CFR 114.100(b)

Maintenance of processing and production records

Cited by Mark E Farrell

20 Jan 2012
21 CFR 114.100(b)

Processing and production - required information

Cited by Mark E Farrell

Inspected site

CSCutone Specialty Foods, Inc.Chelsea, United States

Inspection team

MEMark E Farrell

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 114.100(b)Cited across public-safe Form 483 observations2x
21 CFR 108.25(c)(3)(ii)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(4)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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