Form 483

Decatur Memorial Hospital IRB #1 Form 483, 2010-11-17

FDA issued a Form 483 to Decatur Memorial Hospital IRB #1 on 2010-11-17 with 1 public-safe observation.

483· Form 483 issued1 observation

Decatur Memorial Hospital IRB #1 · Decatur, United States · Issued November 17, 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.

17 Nov 2010
21 CFR 56.108(a)(1)

Initial and continuing reviews

Cited by Susan D Yuscius

Inspected site

DMDecatur Memorial Hospital IRB #1Decatur, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.108(a)(1)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