Atlas

Form 483

American National Red Cross (The) Form 483, 2014-09-26

FDA issued a Form 483 to American National Red Cross (The) on 2014-09-26 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

American National Red Cross (The) · Madison, United States · Issued September 26, 2014

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 4 investigators are tied to this Form 483.

Inspectional observations

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

26 Sep 2014
21 CFR 606.40

Clean & orderly

Cited by Sandra Sejdinovic, Kellie L Thommes, Susan M Miller, Kellie L Westerbuhr

26 Sep 2014
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Sandra Sejdinovic, Kellie L Thommes, Susan M Miller, Kellie L Westerbuhr

26 Sep 2014
21 CFR 606.160(a)(1)

Concurrent documentation

Cited by Sandra Sejdinovic, Kellie L Thommes, Susan M Miller, Kellie L Westerbuhr

Inspected site

ANAmerican National Red Cross (The)Madison, United States

Inspection team

SSSandra Sejdinovic
KLKellie L Thommes
SMSusan M Miller
KLKellie L Westerbuhr

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.160(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 606.40Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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