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Form 483

American National Red Cross Great Lakes Region Form 483, 2010-04-27

FDA issued a Form 483 to American National Red Cross Great Lakes Region on 2010-04-27 with 2 public-safe observations.

483· Form 483 issued2 observations

American National Red Cross Great Lakes Region · Lansing, United States · Issued April 27, 2010

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

27 Apr 2010
21 CFR 606.100(c)

Thorough investigations

Cited by Kelley L Clark

27 Apr 2010
21 CFR 606.170(a)

Adverse Reaction - Investigations

Cited by Kelley L Clark

Inspected site

ANAmerican National Red Cross Great Lakes RegionLansing, United States

Inspection team

KLKelley L Clark

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

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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