Atlas

Form 483

American National Red Cross (The) Form 483, 2015-06-26

FDA issued a Form 483 to American National Red Cross (The) on 2015-06-26 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

American National Red Cross (The) · Madison, United States · Issued June 26, 2015

Overview

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

Inspectional observations

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

26 Jun 2015
21 CFR 606.100(b)

Maintained and followed

Cited by Susan M Miller, Denise L Burosh, Melissa D Kalik

26 Jun 2015
21 CFR 606.160(b)

Required records

Cited by Susan M Miller, Denise L Burosh, Melissa D Kalik

26 Jun 2015
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Susan M Miller, Denise L Burosh, Melissa D Kalik

Inspected site

ANAmerican National Red Cross (The)Madison, United States

Inspection team

SMSusan M Miller
DLDenise L Burosh
MDMelissa D Kalik

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations2x
21 CFR 606.160(b)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