Form 483

Gourmet Gardens Specialty Foods, Inc. Form 483, 2014-02-07

FDA issued a Form 483 to Gourmet Gardens Specialty Foods, Inc. on 2014-02-07 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Gourmet Gardens Specialty Foods, Inc. · Jacksonville, United States · Issued February 7, 2014

Overview

  • 5 public-safe observations are available for this inspection.
  • 4 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.

7 Feb 2014
21 CFR 108.25(c)(2)

Process filing

Cited by Danielle Lyke

7 Feb 2014
21 CFR 108.25(c)(3)(i)

Process adherence

Cited by Danielle Lyke

7 Feb 2014
21 CFR 114.80(b)

Code - required elements

Cited by Danielle Lyke

7 Feb 2014
21 CFR 114.100(b)

Maintenance of processing and production records

Cited by Danielle Lyke

7 Feb 2014
21 CFR 114.100(b)

Processing and production - required information

Cited by Danielle Lyke

Inspected site

GGGourmet Gardens Specialty Foods, Inc.Jacksonville, United States

Inspection team

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)(2)Cited across public-safe Form 483 observations1x
21 CFR 108.25(c)(3)(i)Cited across public-safe Form 483 observations1x
21 CFR 114.80(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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