Atlas

Form 483

Presbyterian/St. Luke's Medical Center Donor Services Form 483, 2014-03-05

FDA issued a Form 483 to Presbyterian/St. Luke's Medical Center Donor Services on 2014-03-05 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Presbyterian/St. Luke's Medical Center Donor Services · Denver, United States · Issued March 5, 2014

Overview

  • 3 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

5 Mar 2014
21 CFR 211.194(a)(8)

Second person sign off

Cited by Daniel P Stlaurent

5 Mar 2014
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Daniel P Stlaurent

5 Mar 2014
21 CFR 606.100(b)

Written SOPs available for use by personnel

Cited by Daniel P Stlaurent

Inspected site

PLPresbyterian/St. Luke's Medical Center Donor ServicesDenver, United States

Inspection team

DPDaniel P Stlaurent

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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