Atlas

Form 483

University of Michigan Center for Reproductive Medicine Form 483, 2018-03-20

FDA issued a Form 483 to University of Michigan Center for Reproductive Medicine on 2018-03-20 with 6 public-safe observations.

483· Form 483 issuedBiologics6 observations

University of Michigan Center for Reproductive Medicine · Ann Arbor, United States · Issued March 20, 2018

Overview

  • 6 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.

20 Mar 2018
21 CFR 1271.47(a)

Donor eligibility procedures

Cited by Erma Zaimova

20 Mar 2018
21 CFR 1271.47(a)

Donor eligibility procedures

Cited by Erma Zaimova

20 Mar 2018
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Erma Zaimova

20 Mar 2018
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Erma Zaimova

20 Mar 2018
21 CFR 1271.80(c)

Kits not FDA approved, specifically labeled

Cited by Erma Zaimova

Inspected site

UOUniversity of Michigan Center for Reproductive MedicineAnn Arbor, United States

Inspection team

EZErma Zaimova

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 1271.75(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 1271.80(c)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 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