Atlas

Form 483

American Red Cross Blood Services Form 483, 2012-08-02

FDA issued a Form 483 to American Red Cross Blood Services on 2012-08-02 with 1 public-safe observation.

483· Form 483 issued1 observation

American Red Cross Blood Services · Boston, United States · Issued August 2, 2012

Overview

  • 1 public-safe observation is 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.

2 Aug 2012
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Kent A Conforti

Inspected site

ARAmerican Red Cross Blood ServicesBoston, United States

Inspection team

KAKent A Conforti

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 1 observation

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