Atlas

Form 483

Gonyek Enterprises Inc. Form 483, 2017-01-05

FDA issued a Form 483 to Gonyek Enterprises Inc. on 2017-01-05 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Gonyek Enterprises Inc. · Edison, United States · Issued January 5, 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.

5 Jan 2017
21 CFR 110.20(b)(2)

Contamination with microorganisms, chemicals, filth, etc.

Cited by Melissa A Freeman

5 Jan 2017
21 CFR 110.35(a)

Buildings/sanitary

Cited by Melissa A Freeman

Inspected site

GEGonyek Enterprises Inc.Edison, United States

Inspection team

MAMelissa A Freeman

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)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