Form 483

World Class Distribution, Inc. Form 483, 2015-05-07

FDA issued a Form 483 to World Class Distribution, Inc. on 2015-05-07 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

World Class Distribution, Inc. · Irving, United States · Issued May 7, 2015

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

7 May 2015
21 CFR 110.37(d)(1)

Maintained

Cited by Dana M Lewis, Denise Connelly

7 May 2015
21 CFR 123.11(c)

Sanitation Records

Cited by Dana M Lewis, Denise Connelly

7 May 2015
21 CFR 123.6(b)

HACCP plan implementation

Cited by Dana M Lewis, Denise Connelly

7 May 2015
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Dana M Lewis, Denise Connelly

7 May 2015
21 CFR 123.6(d)

Signed and dated

Cited by Dana M Lewis, Denise Connelly

Inspected site

WCWorld Class Distribution, Inc.Irving, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.37(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 123.11(c)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x
21 CFR 123.9(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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