Atlas

Form 483

Scripps IRB Form 483, 2009-11-02

FDA issued a Form 483 to Scripps IRB on 2009-11-02 with 4 public-safe observations.

483· Form 483 issued4 observations

Scripps IRB · San Diego, United States · Issued November 2, 2009

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

2 Nov 2009
21 CFR 56.107(d)

One non-affiliate member

Cited by Courtney N Long

2 Nov 2009
21 CFR 56.108(a)(1)

Initial and continuing reviews

Cited by Courtney N Long

2 Nov 2009
21 CFR 56.115(a)(2)

Minutes of IRB meetings

Cited by Courtney N Long

2 Nov 2009
21 CFR 56.115(a)(5)

List of members

Cited by Courtney N Long

Inspected site

SIScripps IRBSan Diego, United States

Inspection team

CNCourtney N Long

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.107(d)Cited across public-safe Form 483 observations1x
21 CFR 56.108(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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