Atlas

Form 483

Asante Health System IRB dba Southern Oregon IRB Form 483, 2017-05-05

FDA issued a Form 483 to Asante Health System IRB dba Southern Oregon IRB on 2017-05-05 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Asante Health System IRB dba Southern Oregon IRB · Medford, United States · Issued May 5, 2017

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.

5 May 2017
21 CFR 56.107(e)

Conflict of interest

Cited by Julian C Hanson

5 May 2017
21 CFR 56.108(a)(1)

Reporting findings and actions to investigator/institution

Cited by Julian C Hanson

5 May 2017
21 CFR 56.108(c)

Members present for review

Cited by Julian C Hanson

Inspected site

AHAsante Health System IRB dba Southern Oregon IRBMedford, United States

Inspection team

JCJulian C Hanson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.107(e)Cited across public-safe Form 483 observations1x
21 CFR 56.108(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 56.108(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