Atlas

Form 483

University of Washington Med Center - Roosevelt Form 483, 2018-06-19

FDA issued a Form 483 to University of Washington Med Center - Roosevelt on 2018-06-19 with 5 public-safe observations.

483· Form 483 issuedBiologics5 observations

University of Washington Med Center - Roosevelt · Seattle, United States · Issued June 19, 2018

Overview

  • 5 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.

19 Jun 2018
21 CFR 1271.47(a)

Donor eligibility procedures

Cited by Peter S Kessler

19 Jun 2018
21 CFR 1271.47(a)

Donor eligibility procedures

Cited by Peter S Kessler

19 Jun 2018
21 CFR 1271.50(b)(1)

Donor screening standards

Cited by Peter S Kessler

19 Jun 2018
21 CFR 1271.50(b)(1)

Donor screening standards

Cited by Peter S Kessler

19 Jun 2018
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Peter S Kessler

Inspected site

UOUniversity of Washington Med Center - RooseveltSeattle, United States

Inspection team

PSPeter S Kessler

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.47(a)Cited across public-safe Form 483 observations3x
21 CFR 1271.50(b)(1)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 5 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