Atlas

Form 483

Oregon Health & Science University Form 483, 2010-10-25

FDA issued a Form 483 to Oregon Health & Science University on 2010-10-25 with 2 public-safe observations.

483· Form 483 issued2 observations

Oregon Health & Science University · Portland, United States · Issued October 25, 2010

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.

25 Oct 2010
21 CFR 1271.80(c)

Manufacturer instructions not followed

Cited by Kathryn A Krentz

25 Oct 2010
21 CFR 1271.180(a)

Procedures to meet core CTGP

Cited by Kathryn A Krentz

Inspected site

OHOregon Health & Science UniversityPortland, United States

Inspection team

KAKathryn A Krentz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.180(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.80(c)Cited 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