Atlas

Form 483

Saint Francis Hospital, Inc. Form 483, 2015-10-22

FDA issued a Form 483 to Saint Francis Hospital, Inc. on 2015-10-22 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Saint Francis Hospital, Inc. · Tulsa, United States · Issued October 22, 2015

Overview

  • 2 public-safe observations are 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 Oct 2015
21 CFR 606.100(b)

Maintained and followed

Cited by Lorie S Hannappel

22 Oct 2015
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Lorie S Hannappel

Inspected site

SFSaint Francis Hospital, Inc.Tulsa, United States

Inspection team

LSLorie S Hannappel

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 observations

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