Form 483

Food Processors (Fiji) Limited Form 483, 2020-02-07

FDA issued a Form 483 to Food Processors (Fiji) Limited on 2020-02-07 with 22 public-safe observations.

483· Form 483 issuedFoods & Cosmetics22 observations

Food Processors (Fiji) Limited · Suva, Fiji · Issued February 7, 2020

Overview

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

7 Feb 2020
21 CFR 108.35(c)(3)(i)

Process adherence

Cited by Richard G Fochesato

7 Feb 2020
21 CFR 108.35(c)(3)(i)

Process adherence

Cited by Richard G Fochesato

7 Feb 2020
21 CFR 108.35(f)

Recall procedures

Cited by Richard G Fochesato

7 Feb 2020
21 CFR 108.35(f)

Recall procedures

Cited by Richard G Fochesato

7 Feb 2020
21 CFR 108.35(g)

Approved school

Cited by Richard G Fochesato

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 113.100(b)Cited across public-safe Form 483 observations4x
21 CFR 108.35(c)(3)(i)Cited across public-safe Form 483 observations2x
21 CFR 108.35(f)Cited across public-safe Form 483 observations2x
21 CFR 108.35(g)Cited across public-safe Form 483 observations2x
21 CFR 113.40(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 113.40(a)(1)(iv)Cited across public-safe Form 483 observations2x
21 CFR 113.40(a)(11)Cited across public-safe Form 483 observations2x
21 CFR 113.60(c)Cited across public-safe Form 483 observations2x
21 CFR 113.83Cited across public-safe Form 483 observations2x
21 CFR 113.87(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 22 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