Form 483

Global Packaging Systems, Inc Form 483, 2013-01-15

FDA issued a Form 483 to Global Packaging Systems, Inc on 2013-01-15 with 2 public-safe observations.

483· Form 483 issued2 observations

Global Packaging Systems, Inc · Fort Worth, United States · Issued January 15, 2013

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.

15 Jan 2013
21 CFR 211.130(e)

Packaging line inspection before use

Cited by Hala L Selby, Yaw O Osei

15 Jan 2013
21 CFR 211.182

Written records kept in individual logs

Cited by Hala L Selby, Yaw O Osei

Inspected site

GPGlobal Packaging Systems, IncFort Worth, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.130(e)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited 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