Atlas

Form 483

Marianne Brodmann, MD Form 483, 2019-03-22

FDA issued a Form 483 to Marianne Brodmann, MD on 2019-03-22 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Marianne Brodmann, MD · Graz, Austria · Issued March 22, 2019

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.

22 Mar 2019
21 CFR 812.110(b)

Investigator non-compliance with agreement/plan/regulations

Cited by Lequita M Mayhew

Inspected site

MBMarianne Brodmann, MDGraz, Austria

Inspection team

LMLequita M Mayhew

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 812.110(b)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