Atlas

Form 483

Diamond Institute for Infertility and Menopause Form 483, 2012-05-24

FDA issued a Form 483 to Diamond Institute for Infertility and Menopause on 2012-05-24 with 2 public-safe observations.

483· Form 483 issued2 observations

Diamond Institute for Infertility and Menopause · Millburn, United States · Issued May 24, 2012

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.

24 May 2012
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Christina N Maurino

24 May 2012
21 CFR 1271.75(d)

Donors with risks not determined ineligible

Cited by Christina N Maurino

Inspected site

DIDiamond Institute for Infertility and MenopauseMillburn, United States

Inspection team

CNChristina N Maurino

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.47(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.75(d)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