Atlas

Form 483

Mary Crowley Medical Research Center IRB Form 483, 2014-09-09

FDA issued a Form 483 to Mary Crowley Medical Research Center IRB on 2014-09-09 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Mary Crowley Medical Research Center IRB · Dallas, United States · Issued September 9, 2014

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.

9 Sep 2014
21 CFR 56.111(c)

Children as subjects

Cited by Elisa M Fleming

Inspected site

MCMary Crowley Medical Research Center IRBDallas, United States

Inspection team

EMElisa M Fleming

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.111(c)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