Form 483

Adesa International, LLC Form 483, 2015-09-24

FDA issued a Form 483 to Adesa International, LLC on 2015-09-24 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

Adesa International, LLC · Ontario, United States · Issued September 24, 2015

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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 Sep 2015
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Phal K Chhun

24 Sep 2015
21 CFR 110.20(b)(6)

Adequate ventilation

Cited by Phal K Chhun

24 Sep 2015
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Phal K Chhun

24 Sep 2015
21 CFR 110.37(b)(3)

As source of contamination

Cited by Phal K Chhun

24 Sep 2015
21 CFR 110.40(a)

Materials and workmanship

Cited by Phal K Chhun

Inspected site

AIAdesa International, LLCOntario, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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