Atlas

Form 483

The American National Red Cross Form 483, 2014-12-29

FDA issued a Form 483 to The American National Red Cross on 2014-12-29 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

The American National Red Cross · Farmington Hills, United States · Issued December 29, 2014

Overview

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

Inspectional observations

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

29 Dec 2014
21 CFR 606.100(b)

Maintained and followed

Cited by Barbara A Rusin

29 Dec 2014
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Barbara A Rusin

Inspected site

TAThe American National Red CrossFarmington Hills, United States

Inspection team

BABarbara A Rusin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations2x

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