Atlas

Form 483

The American National Red Cross Form 483, 2010-02-09

FDA issued a Form 483 to The American National Red Cross on 2010-02-09 with 2 public-safe observations.

483· Form 483 issued2 observations

The American National Red Cross · Columbus, United States · Issued February 9, 2010

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.

9 Feb 2010
21 CFR 606.160(b)

Required records

Cited by Cordelia J Brammer

9 Feb 2010
21 CFR 640.3(a)(1)

Donor suitability procedures not followed

Cited by Cordelia J Brammer

Inspected site

TAThe American National Red CrossColumbus, United States

Inspection team

CJCordelia J Brammer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.160(b)Cited across public-safe Form 483 observations1x
21 CFR 640.3(a)(1)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