Form 483

The Jel Sert Company Form 483, 2022-08-11

FDA issued a Form 483 to The Jel Sert Company on 2022-08-11 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

The Jel Sert Company · West Chicago, United States · Issued August 11, 2022

Overview

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

Inspectional observations

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

11 Aug 2022
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by Liliya V Bubiy, Daniel B Arrecis

11 Aug 2022
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by Liliya V Bubiy, Daniel B Arrecis

11 Aug 2022
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by Liliya V Bubiy, Daniel B Arrecis

Inspected site

TJThe Jel Sert CompanyWest Chicago, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.35(a)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 3 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