Form 483

Big Gus Onion Rings Inc Form 483, 2019-09-27

FDA issued a Form 483 to Big Gus Onion Rings Inc on 2019-09-27 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Big Gus Onion Rings Inc · Willoughby Hills, United States · Issued September 27, 2019

Overview

  • 8 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.

27 Sep 2019
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Amy L Mccarthy, Said H Muse

27 Sep 2019
21 CFR 117.130(a)(1)

Hazard Analysis - Identification of Hazard

Cited by Amy L Mccarthy, Said H Muse

27 Sep 2019
21 CFR 117.145(a)

Allergen Controls Monitoring Proced: Establish Implement

Cited by Amy L Mccarthy, Said H Muse

27 Sep 2019
21 CFR 117.145(a)

Allergen Controls Monitoring Proced: Establish Implement

Cited by Amy L Mccarthy, Said H Muse

27 Sep 2019
21 CFR 117.145(a)

Process Controls Monitoring Procedures: Establish Implement

Cited by Amy L Mccarthy, Said H Muse

Inspected site

BGBig Gus Onion Rings IncWilloughby Hills, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.145(a)Cited across public-safe Form 483 observations6x
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 observations

The full inspection record, as Atlas holds it, 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