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Form 483

Stanford Blood Center, LLC Form 483, 2011-12-22

FDA issued a Form 483 to Stanford Blood Center, LLC on 2011-12-22 with 1 public-safe observation.

483· Form 483 issued1 observation

Stanford Blood Center, LLC · Menlo Park, United States · Issued December 22, 2011

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.

22 Dec 2011
21 CFR 606.160(b)

Required records

Cited by Mary E Wilkerson-Brinsko

Inspected site

SBStanford Blood Center, LLCMenlo Park, United States

Inspection team

MEMary E Wilkerson-Brinsko

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.160(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