Form 483

American Red Cross Blood Svcs Form 483, 2015-08-07

FDA issued a Form 483 to American Red Cross Blood Svcs on 2015-08-07 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

American Red Cross Blood Svcs · Durham, United States · Issued August 7, 2015

Overview

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

Inspectional observations

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

7 Aug 2015
21 CFR 640.4(f)

Arm preparation

Cited by Randy L Clarida, Marla A Cassidy

Inspected site

ARAmerican Red Cross Blood SvcsDurham, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 640.4(f)Cited across public-safe Form 483 observations1x

Full 483 report

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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