Atlas

Form 483

The National American Red Cross Form 483, 2008-10-17

FDA issued a Form 483 to The National American Red Cross on 2008-10-17 with 3 public-safe observations.

483· Form 483 issued3 observations

The National American Red Cross · Peoria, United States · Issued October 17, 2008

Overview

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

Inspectional observations

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

17 Oct 2008
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Laurie A Haxel

17 Oct 2008
21 CFR 606.100(c)

Thorough investigations

Cited by Laurie A Haxel

17 Oct 2008
21 CFR 606.170(a)

Adverse Reaction - Investigations

Cited by Laurie A Haxel

Inspected site

TNThe National American Red CrossPeoria, United States

Inspection team

LALaurie A Haxel

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 606.100(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 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