Form 483

Intermex Products USA, Ltd Form 483, 2008-10-16

FDA issued a Form 483 to Intermex Products USA, Ltd on 2008-10-16 with 6 public-safe observations.

483· Form 483 issued6 observations

Intermex Products USA, Ltd · Grand Prairie, United States · Issued October 16, 2008

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.

16 Oct 2008
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Charles D Brown, Kenitra D Hewitt

16 Oct 2008
21 CFR 110.80(a)(1)

Storage

Cited by Charles D Brown, Kenitra D Hewitt

16 Oct 2008
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Charles D Brown, Kenitra D Hewitt

16 Oct 2008
21 CFR 110.80(b)(5)

Work-in-progress

Cited by Charles D Brown, Kenitra D Hewitt

16 Oct 2008
21 CFR 110.80(b)(7)

Equipment, containers, utensils

Cited by Charles D Brown, Kenitra D Hewitt

Inspected site

IPIntermex Products USA, LtdGrand Prairie, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(13)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)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