Atlas

Form 483

Illume Fertility Form 483, 2016-04-06

FDA issued a Form 483 to Illume Fertility on 2016-04-06 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Illume Fertility · Norwalk, United States · Issued April 6, 2016

Overview

  • 3 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.

6 Apr 2016
21 CFR 1271.47(a)

Procedures for all steps

Cited by Anthony N Onianwa

6 Apr 2016
21 CFR 1271.50(a)

Determination based on screening and testing

Cited by Anthony N Onianwa

6 Apr 2016
21 CFR 1271.47(a)

Procedures for all other requirements

Cited by Anthony N Onianwa

Inspected site

IFIllume FertilityNorwalk, United States

Inspection team

ANAnthony N Onianwa

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.47(a)Cited across public-safe Form 483 observations2x
21 CFR 1271.50(a)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