Atlas

Form 483

Saint Francis Medical Center Form 483, 2013-09-10

FDA issued a Form 483 to Saint Francis Medical Center on 2013-09-10 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Saint Francis Medical Center · Cape Girardeau, United States · Issued September 10, 2013

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.

10 Sep 2013
21 CFR 56.115(a)(2)

Minutes of IRB meetings

Cited by Steven D Kehoe

Inspected site

SFSaint Francis Medical CenterCape Girardeau, United States

Inspection team

SDSteven D Kehoe

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.115(a)(2)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