Atlas

Form 483

The American National Red Cross Form 483, 2013-06-07

FDA issued a Form 483 to The American National Red Cross on 2013-06-07 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

The American National Red Cross · Fort Wayne, United States · Issued June 7, 2013

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.

7 Jun 2013
21 CFR 606.170(a)

Adverse reaction - Maintenance of Reports

Cited by Sherri J Jackson, Andrea D Swingle

Inspected site

TAThe American National Red CrossFort Wayne, United States

Inspection team

SJSherri J Jackson
ADAndrea D Swingle

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.170(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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