Atlas

Form 483

The Fertility Center of Oregon Form 483, 2022-04-13

FDA issued a Form 483 to The Fertility Center of Oregon on 2022-04-13 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

The Fertility Center of Oregon · Eugene, United States · Issued April 13, 2022

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.

13 Apr 2022
21 CFR 1271.80(c)

Kits not FDA approved, specifically labeled

Cited by Paul M Chefor

13 Apr 2022
21 CFR 1271.85(a)

Infection with communicable disease agents

Cited by Paul M Chefor

Inspected site

TFThe Fertility Center of OregonEugene, United States

Inspection team

PMPaul M Chefor

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.80(c)Cited across public-safe Form 483 observations1x
21 CFR 1271.85(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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