Form 483

Pt Dua Kelinci Form 483, 2023-08-23

FDA issued a Form 483 to Pt Dua Kelinci on 2023-08-23 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Pt Dua Kelinci · Pati, Indonesia · Issued August 23, 2023

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

23 Aug 2023
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by Brandi E Williams

23 Aug 2023
21 CFR 117.35(d)

Sanitation of food-contact surfaces - Frequency

Cited by Brandi E Williams

Inspected site

PDPt Dua KelinciPati, Indonesia

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 observations1x
21 CFR 117.35(d)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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