Atlas

Form 483

Core-Mark US, LLC Form 483, 2014-09-24

FDA issued a Form 483 to Core-Mark US, LLC on 2014-09-24 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Core-Mark US, LLC · Houston, United States · Issued September 24, 2014

Overview

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

24 Sep 2014
21 CFR 123.6(c)(3)

Critical limits

Cited by Frans E Mercado, Constance M Dobbins

24 Sep 2014
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Frans E Mercado, Constance M Dobbins

Inspected site

CUCore-Mark US, LLCHouston, United States

Inspection team

FEFrans E Mercado
CMConstance M Dobbins

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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