Atlas

Form 483

Henry Ford Center for Reproductive Medicine Form 483, 2012-11-14

FDA issued a Form 483 to Henry Ford Center for Reproductive Medicine on 2012-11-14 with 3 public-safe observations.

483· Form 483 issued3 observations

Henry Ford Center for Reproductive Medicine · Troy, United States · Issued November 14, 2012

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

14 Nov 2012
21 CFR 1271.47(a)

Procedures for all other requirements

Cited by Barbara A Rusin

14 Nov 2012
21 CFR 1271.47(b)

Review and approval of procedures

Cited by Barbara A Rusin

14 Nov 2012
21 CFR 1271.60(a)

Completion of eligibility determination

Cited by Barbara A Rusin

Inspected site

HFHenry Ford Center for Reproductive MedicineTroy, United States

Inspection team

BABarbara A Rusin

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 1271.47(b)Cited across public-safe Form 483 observations1x
21 CFR 1271.60(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