Form 483

American National Red Cross (The) Carolinas Region Form 483, 2010-07-21

FDA issued a Form 483 to American National Red Cross (The) Carolinas Region on 2010-07-21 with 2 public-safe observations.

483· Form 483 issued2 observations

American National Red Cross (The) Carolinas Region · Charlotte, United States · Issued July 21, 2010

Overview

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

Inspectional observations

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

21 Jul 2010
21 CFR 606.100(c)

Thorough investigations

Cited by Randy L Clarida, Cordelia J Brammer, Kimberly C Delk-Brooks, Esra Toussaint, Pamela L Vega

21 Jul 2010
21 CFR 606.170(a)

Adverse Reaction- Reports of Investigations

Cited by Randy L Clarida, Cordelia J Brammer, Kimberly C Delk-Brooks, Esra Toussaint, Pamela L Vega

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(c)Cited across public-safe Form 483 observations1x
21 CFR 606.170(a)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