Atlas

Form 483

The Fertility Center of Oregon Form 483, 2015-02-20

FDA issued a Form 483 to The Fertility Center of Oregon on 2015-02-20 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

The Fertility Center of Oregon · Eugene, United States · Issued February 20, 2015

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.

20 Feb 2015
21 CFR 1271.55(c)

Name and personal info on accompanying records

Cited by Julian C Hanson

20 Feb 2015
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Julian C Hanson

Inspected site

TFThe Fertility Center of OregonEugene, United States

Inspection team

JCJulian C Hanson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
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 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