Form 483

Garden Fresh Gourmet, LLC Form 483, 2017-06-16

FDA issued a Form 483 to Garden Fresh Gourmet, LLC on 2017-06-16 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Garden Fresh Gourmet, LLC · Ferndale, United States · Issued June 16, 2017

Overview

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

16 Jun 2017
21 CFR 117.37

Sanitary Facilities and Control

Cited by Michelle L Jones

16 Jun 2017
21 CFR 117.80(c)

Manufacturing, Processing, Packing, Holding - Controls

Cited by Michelle L Jones

Inspected site

GFGarden Fresh Gourmet, LLCFerndale, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.37Cited across public-safe Form 483 observations1x
21 CFR 117.80(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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