Form 483

Gedney Foods Company Form 483, 2016-06-10

FDA issued a Form 483 to Gedney Foods Company on 2016-06-10 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Gedney Foods Company · Chaska, United States · Issued June 10, 2016

Overview

  • 4 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.

10 Jun 2016
21 CFR 110.35(a)

Buildings/sanitary

Cited by Amy L Mcintyre

10 Jun 2016
21 CFR 110.80(b)(5)

Work-in-progress

Cited by Amy L Mcintyre

10 Jun 2016
21 CFR 110.80(b)(7)

Equipment, containers, utensils

Cited by Amy L Mcintyre

10 Jun 2016
21 CFR 114.80(b)

Code - required elements

Cited by Amy L Mcintyre

Inspected site

GFGedney Foods CompanyChaska, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)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 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