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Form 483

St Luke's Hospital IRB Form 483, 2022-04-29

FDA issued a Form 483 to St Luke's Hospital IRB on 2022-04-29 with 6 public-safe observations.

483· Form 483 issuedBiologics6 observations

St Luke's Hospital IRB · Chesterfield, United States · Issued April 29, 2022

Overview

  • 6 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.

29 Apr 2022
21 CFR 1271.55(c)

Name and personal info on accompanying records

Cited by Elmina E Akwo

29 Apr 2022
21 CFR 1271.55(c)

Name and personal info on accompanying records

Cited by Elmina E Akwo

29 Apr 2022
21 CFR 1271.55(c)

Name and personal info on accompanying records

Cited by Elmina E Akwo

29 Apr 2022
21 CFR 1271.90(c)

Eligibility not required--warning labels

Cited by Elmina E Akwo

29 Apr 2022
21 CFR 1271.90(c)

Eligibility not required--warning labels

Cited by Elmina E Akwo

Inspected site

SLSt Luke's Hospital IRBChesterfield, United States

Inspection team

EEElmina E Akwo

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.55(c)Cited across public-safe Form 483 observations3x
21 CFR 1271.90(c)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 6 observations

The full inspection record, as Atlas holds it, 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