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Form 483

Seton Family of Hospitals Institutional Review Board (SFOH IRB) Form 483, 2019-03-22

FDA issued a Form 483 to Seton Family of Hospitals Institutional Review Board (SFOH IRB) on 2019-03-22 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Seton Family of Hospitals Institutional Review Board (SFOH IRB) · Austin, United States · Issued March 22, 2019

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

22 Mar 2019
21 CFR 56.109(f)

Continuing review

Cited by Leighton K Ngai

22 Mar 2019
21 CFR 56.109(h)

Children as subjects

Cited by Leighton K Ngai

22 Mar 2019
21 CFR 56.115(b)

Retention of records

Cited by Leighton K Ngai

Inspected site

SFSeton Family of Hospitals Institutional Review Board (SFOH IRB)Austin, United States

Inspection team

LKLeighton K Ngai

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.109(f)Cited across public-safe Form 483 observations1x
21 CFR 56.109(h)Cited across public-safe Form 483 observations1x
21 CFR 56.115(b)Cited across public-safe Form 483 observations1x

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 3 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