Atlas

Form 483

Thomas Jefferson University Hospital Form 483, 2009-10-23

FDA issued a Form 483 to Thomas Jefferson University Hospital on 2009-10-23 with 2 public-safe observations.

483· Form 483 issued2 observations

Thomas Jefferson University Hospital · Philadelphia, United States · Issued October 23, 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.

23 Oct 2009
21 CFR 606.171

Biological product deviation report

Cited by Gayle S Lawson

23 Oct 2009
21 CFR 610.47

Notification of transfusion recipients

Cited by Gayle S Lawson

Inspected site

TJThomas Jefferson University HospitalPhiladelphia, United States

Inspection team

GSGayle S Lawson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.171Cited across public-safe Form 483 observations1x
21 CFR 610.47Cited 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