Atlas

Form 483

The American National Red Cross - Southern Region Form 483, 2011-07-22

FDA issued a Form 483 to The American National Red Cross - Southern Region on 2011-07-22 with 3 public-safe observations.

483· Form 483 issued3 observations

The American National Red Cross - Southern Region · Douglasville, United States · Issued July 22, 2011

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.

22 Jul 2011
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Jessica Fields, Randy L Clarida, Kimberly C Delk-Brooks, Esra Toussaint

22 Jul 2011
21 CFR 606.160(a)(1)

Concurrent documentation

Cited by Jessica Fields, Randy L Clarida, Kimberly C Delk-Brooks, Esra Toussaint

22 Jul 2011
21 CFR 630.40(c)

Documentation

Cited by Jessica Fields, Randy L Clarida, Kimberly C Delk-Brooks, Esra Toussaint

Inspected site

TAThe American National Red Cross - Southern RegionDouglasville, United States

Inspection team

JFJessica Fields
RLRandy L Clarida
KCKimberly C Delk-Brooks
ETEsra Toussaint

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 630.40(c)Cited 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