Form 483

Center for Reproductive Medicine Form 483, 2012-08-06

FDA issued a Form 483 to Center for Reproductive Medicine on 2012-08-06 with 1 public-safe observation.

483· Form 483 issued1 observation

Center for Reproductive Medicine · Minneapolis, United States · Issued August 6, 2012

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is 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 Aug 2012
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Sandra Sejdinovic

Inspected site

CFCenter for Reproductive MedicineMinneapolis, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 1 observation

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