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Form 483

American National Red Cross (The) Form 483, 2010-04-23

FDA issued a Form 483 to American National Red Cross (The) on 2010-04-23 with 1 public-safe observation.

483· Form 483 issued1 observation

American National Red Cross (The) · Madison, United States · Issued April 23, 2010

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

23 Apr 2010
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Karen M Labounty, Susan M Miller

Inspected site

ANAmerican National Red Cross (The)Madison, United States

Inspection team

KMKaren M Labounty
SMSusan M Miller

Cited regulations

CFR citations associated with this Form 483.

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

Source document

PDF
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Form 483 source document

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Full 483 report

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The source PDF and 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