Atlas

Form 483

Advocate Christ Medical Center Transfusion Services Form 483, 2009-02-04

FDA issued a Form 483 to Advocate Christ Medical Center Transfusion Services on 2009-02-04 with 2 public-safe observations.

483· Form 483 issued2 observations

Advocate Christ Medical Center Transfusion Services · Oak Lawn, United States · Issued February 4, 2009

Overview

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

Inspectional observations

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

4 Feb 2009
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Lequita M Mayhew

4 Feb 2009
21 CFR 606.160(a)(1)

Person performing, test results, interpretation

Cited by Lequita M Mayhew

Inspected site

ACAdvocate Christ Medical Center Transfusion ServicesOak Lawn, United States

Inspection team

LMLequita M Mayhew

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.160(a)(1)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