Form 483

Arcade Marketing Inc. Form 483, 2012-04-10

FDA issued a Form 483 to Arcade Marketing Inc. on 2012-04-10 with 5 public-safe observations.

483· Form 483 issued5 observations

Arcade Marketing Inc. · Chattanooga, United States · Issued April 10, 2012

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

10 Apr 2012
21 CFR 211.84(d)(1)

Identity Testing of Each Component

Cited by Brandon C Heitmeier

10 Apr 2012
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Brandon C Heitmeier

10 Apr 2012
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Brandon C Heitmeier

10 Apr 2012
21 CFR 211.165(a)

Testing and release for distribution

Cited by Brandon C Heitmeier

10 Apr 2012
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Brandon C Heitmeier

Inspected site

AMArcade Marketing Inc.Chattanooga, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(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