Form 483

Dockers International Llc Form 483, 2009-11-12

FDA issued a Form 483 to Dockers International Llc on 2009-11-12 with 4 public-safe observations.

483· Form 483 issued4 observations

Dockers International Llc · Elkridge, United States · Issued November 12, 2009

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

12 Nov 2009
21 CFR 110.20(b)(1)

Sufficient space

Cited by Elvis D Morton

12 Nov 2009
21 CFR 110.37(e)(5)

Signs

Cited by Elvis D Morton

12 Nov 2009
21 CFR 123.6(a)

Hazard analysis

Cited by Elvis D Morton

12 Nov 2009
21 CFR 123.11(c)

Sanitation Records

Cited by Elvis D Morton

Inspected site

DIDockers International LlcElkridge, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.11(c)Cited across public-safe Form 483 observations1x
21 CFR 123.6(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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