Atlas

Form 483

Froedtert Hospital Reproductive Medicine Center Form 483, 2010-02-04

FDA issued a Form 483 to Froedtert Hospital Reproductive Medicine Center on 2010-02-04 with 1 public-safe observation.

483· Form 483 issued1 observation

Froedtert Hospital Reproductive Medicine Center · Menomonee Falls, United States · Issued February 4, 2010

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.

4 Feb 2010
21 CFR 1271.55(a)(3)

Summary--records used to make determination

Cited by Denise L Burosh

Inspected site

FHFroedtert Hospital Reproductive Medicine CenterMenomonee Falls, United States

Inspection team

DLDenise L Burosh

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.55(a)(3)Cited across public-safe Form 483 observations1x

Full 483 report

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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