Form 483

Gehl Foods, LLC Form 483, 2017-05-24

FDA issued a Form 483 to Gehl Foods, LLC on 2017-05-24 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Gehl Foods, LLC · Germantown, United States · Issued May 24, 2017

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

24 May 2017
21 CFR 113.100(b)

Review not signed/dated

Cited by Jon C Polzine, Jennifer Guttuso

24 May 2017
21 CFR 113.40(g)(1)(i)(A)(5)

TID not reference instrument

Cited by Jon C Polzine, Jennifer Guttuso

Inspected site

GFGehl Foods, LLCGermantown, United States

Inspection team

JCJon C Polzine

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 113.100(b)Cited across public-safe Form 483 observations1x
21 CFR 113.40(g)(1)(i)(A)(5)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