Form 483

Food Processors (Fiji) Limited Form 483, 2012-07-24

FDA issued a Form 483 to Food Processors (Fiji) Limited on 2012-07-24 with 12 public-safe observations.

483· Form 483 issued12 observations

Food Processors (Fiji) Limited · Suva, Fiji · Issued July 24, 2012

Overview

  • 12 public-safe observations are available for this inspection.
  • 12 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.

24 Jul 2012
21 CFR 108.35(c)(3)(i)

Process adherence

Cited by Lisa M Thursam

24 Jul 2012
21 CFR 110.20(b)(7)

Screening

Cited by Lisa M Thursam

24 Jul 2012
21 CFR 113.40(a)(1)

TID accuracy test frequency

Cited by Lisa M Thursam

24 Jul 2012
21 CFR 113.40(a)(1)(iv)

MIG - range

Cited by Lisa M Thursam

24 Jul 2012
21 CFR 113.40(a)(1)(v)

TID not reference instrument

Cited by Lisa M Thursam

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 108.35(c)(3)(i)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 113.100(b)Cited across public-safe Form 483 observations1x
21 CFR 113.40(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 113.40(a)(1)(iv)Cited across public-safe Form 483 observations1x
21 CFR 113.40(a)(1)(v)Cited across public-safe Form 483 observations1x
21 CFR 113.40(a)(2)(iii)Cited across public-safe Form 483 observations1x
21 CFR 113.60(c)Cited across public-safe Form 483 observations1x
21 CFR 113.83Cited across public-safe Form 483 observations1x
21 CFR 113.87(b)Cited across public-safe Form 483 observations1x
21 CFR 113.87(g)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 12 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