Form 483

University of Washington Med Center - Roosevelt Form 483, 2026-02-20

FDA issued a Form 483 to University of Washington Med Center - Roosevelt on 2026-02-20 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

University of Washington Med Center - Roosevelt · Seattle, United States · Issued February 20, 2026

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.

20 Feb 2026
21 CFR 1271.50(a)

Responsible person to determine, document

Cited by Kaarin M Slotte

20 Feb 2026
21 CFR 1271.55(c)

Name and personal info on accompanying records

Cited by Kaarin M Slotte

20 Feb 2026
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Kaarin M Slotte

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.50(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.55(c)Cited across public-safe Form 483 observations1x
21 CFR 1271.75(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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