Atlas

Form 483

Fertility Unlimited Inc. Form 483, 2011-12-28

FDA issued a Form 483 to Fertility Unlimited Inc. on 2011-12-28 with 2 public-safe observations.

483· Form 483 issued2 observations

Fertility Unlimited Inc. · Akron, United States · Issued December 28, 2011

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.

28 Dec 2011
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Nancy L Neiger

28 Dec 2011
21 CFR 1271.80(c)

Kits not FDA approved, specifically labeled

Cited by Nancy L Neiger

Inspected site

FUFertility Unlimited Inc.Akron, United States

Inspection team

NLNancy L Neiger

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.75(a)(1)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