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Form 483

St Luke's Hospital Assisted Reproductive Technology Lab Form 483, 2019-05-23

FDA issued a Form 483 to St Luke's Hospital Assisted Reproductive Technology Lab on 2019-05-23 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

St Luke's Hospital Assisted Reproductive Technology Lab · Chesterfield, United States · Issued May 23, 2019

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.

23 May 2019
21 CFR 1271.85(a)

Infection with communicable disease agents

Cited by Kathleen B Swat

23 May 2019
21 CFR 1271.85(a)

Infection with communicable disease agents

Cited by Kathleen B Swat

Inspected site

SLSt Luke's Hospital Assisted Reproductive Technology LabChesterfield, United States

Inspection team

KBKathleen B Swat

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.85(a)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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