Form 483

Jusin Foods Co. LTD Form 483, 2020-02-11

FDA issued a Form 483 to Jusin Foods Co. LTD on 2020-02-11 with 20 public-safe observations.

483· Form 483 issuedFoods & Cosmetics20 observations

Jusin Foods Co. LTD · Uljin, Korea (the Republic of) · Issued February 11, 2020

Overview

  • 20 public-safe observations are available for this inspection.
  • 10 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.

11 Feb 2020
21 CFR 117.35(a)

Sanitary Operations - Plant Sanitation

Cited by Siobhan A Gallagher, Siobhan G Taylor

11 Feb 2020
21 CFR 117.35(a)

Sanitary Operations - Plant Sanitation

Cited by Siobhan A Gallagher, Siobhan G Taylor

11 Feb 2020
21 CFR 123.11(b)

Sanitation monitoring

Cited by Siobhan A Gallagher, Siobhan G Taylor

11 Feb 2020
21 CFR 123.11(b)

Sanitation monitoring

Cited by Siobhan A Gallagher, Siobhan G Taylor

11 Feb 2020
21 CFR 123.6(b)

HACCP plan location

Cited by Siobhan A Gallagher, Siobhan G Taylor

Inspected site

JFJusin Foods Co. LTDUljin, Korea (the Republic of)

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 observations2x
21 CFR 123.11(b)Cited across public-safe Form 483 observations2x
21 CFR 123.6(b)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(1)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations2x
21 CFR 123.6(c)(7)Cited across public-safe Form 483 observations2x
21 CFR 123.6(d)Cited across public-safe Form 483 observations2x
21 CFR 123.8(a)(3)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 20 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