Atlas

Form 483

The American National Red Cross Form 483, 2011-09-02

FDA issued a Form 483 to The American National Red Cross on 2011-09-02 with 2 public-safe observations.

483· Form 483 issued2 observations

The American National Red Cross · Norfolk, United States · Issued September 2, 2011

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

2 Sep 2011
21 CFR 211.188(b)(2)

Identity of major equipment and lines used

Cited by Marion W Nadeau

2 Sep 2011
21 CFR 606.100(c)

Record review prior to release

Cited by Marion W Nadeau

Inspected site

TAThe American National Red CrossNorfolk, United States

Inspection team

MWMarion W Nadeau

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.188(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 606.100(c)Cited 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