Atlas

Form 483

University Medical Center of Princeton at Plainsboro Form 483, 2013-07-19

FDA issued a Form 483 to University Medical Center of Princeton at Plainsboro on 2013-07-19 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

University Medical Center of Princeton at Plainsboro · Plainsboro, United States · Issued July 19, 2013

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.

19 Jul 2013
21 CFR 606.160(e)(1)

Donor deferral record - each location

Cited by Sarah M Forney

Inspected site

UMUniversity Medical Center of Princeton at PlainsboroPlainsboro, United States

Inspection team

SMSarah M Forney

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.160(e)(1)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