Atlas

Form 483

The Fertility Center of Oregon Form 483, 2018-03-27

FDA issued a Form 483 to The Fertility Center of Oregon on 2018-03-27 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

The Fertility Center of Oregon · Eugene, United States · Issued March 27, 2018

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

27 Mar 2018
21 CFR 1271.85(a)

Infection with communicable disease agents

Cited by Kathryn A Krentz

27 Mar 2018
21 CFR 1271.85(a)

Infection with communicable disease agents

Cited by Kathryn A Krentz

Inspected site

TFThe Fertility Center of OregonEugene, United States

Inspection team

KAKathryn A Krentz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.85(a)Cited across public-safe Form 483 observations2x

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