Atlas

Form 483

American Red Cross Blood Services Form 483, 2011-09-23

FDA issued a Form 483 to American Red Cross Blood Services on 2011-09-23 with 2 public-safe observations.

483· Form 483 issued2 observations

American Red Cross Blood Services · Birmingham, United States · Issued September 23, 2011

Overview

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

Inspectional observations

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

23 Sep 2011
21 CFR 211.105(b)

Distinctive ID or code not recorded in batch record

Cited by Kip J Hanks, Cheryl L Watson

23 Sep 2011
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Kip J Hanks, Cheryl L Watson

Inspected site

ARAmerican Red Cross Blood ServicesBirmingham, United States

Inspection team

KJKip J Hanks
CLCheryl L Watson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.105(b)Cited across public-safe Form 483 observations1x
21 CFR 606.100(b)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