Atlas

Form 483

Thomas Jefferson University Hospital Form 483, 2011-11-23

FDA issued a Form 483 to Thomas Jefferson University Hospital on 2011-11-23 with 3 public-safe observations.

483· Form 483 issued3 observations

Thomas Jefferson University Hospital · Philadelphia, United States · Issued November 23, 2011

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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 Nov 2011
21 CFR 606.100(c)

Thorough investigations

Cited by Linda M Hoover

23 Nov 2011
21 CFR 606.171

Biological product deviation report

Cited by Linda M Hoover

23 Nov 2011
21 CFR 630.40(c)

Documentation

Cited by Linda M Hoover

Inspected site

TJThomas Jefferson University HospitalPhiladelphia, United States

Inspection team

LMLinda M Hoover

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(c)Cited across public-safe Form 483 observations1x
21 CFR 606.171Cited across public-safe Form 483 observations1x
21 CFR 630.40(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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