Form 483

Global Product Management, Inc. Form 483, 2011-03-07

FDA issued a Form 483 to Global Product Management, Inc. on 2011-03-07 with 5 public-safe observations.

483· Form 483 issued5 observations

Global Product Management, Inc. · Monrovia, United States · Issued March 7, 2011

Overview

  • 5 public-safe observations are available for this inspection.
  • 4 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 Mar 2011
21 CFR 111.103

Written procedures - quality control operations

Cited by Marcus F Yambot, Julia Ventura

7 Mar 2011
21 CFR 111.105(i)

QC required operations production and process control

Cited by Marcus F Yambot, Julia Ventura

7 Mar 2011
21 CFR 111.105(i)

Quality control - required operations product complaints

Cited by Marcus F Yambot, Julia Ventura

7 Mar 2011
21 CFR 111.315(b)(5)

Sampling plans; packaged, labeled dietary supplement, QC

Cited by Marcus F Yambot, Julia Ventura

7 Mar 2011
21 CFR 111.570(b)(1)

Written procedures - product complaint; review, investigate

Cited by Marcus F Yambot, Julia Ventura

Inspected site

GPGlobal Product Management, Inc.Monrovia, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.105(i)Cited across public-safe Form 483 observations2x
21 CFR 111.103Cited across public-safe Form 483 observations1x
21 CFR 111.315(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 111.570(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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