Atlas

Form 483

Joslin Diabetes Center Committee on Human Studies Form 483, 2009-10-02

FDA issued a Form 483 to Joslin Diabetes Center Committee on Human Studies on 2009-10-02 with 3 public-safe observations.

483· Form 483 issued3 observations

Joslin Diabetes Center Committee on Human Studies · Boston, United States · Issued October 2, 2009

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.

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

Initial and continuing reviews

Cited by Michelle M Noe

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

Reporting findings and actions to investigator/institution

Cited by Michelle M Noe

2 Oct 2009
21 CFR 56.109(h)

Children as subjects

Cited by Michelle M Noe

Inspected site

JDJoslin Diabetes Center Committee on Human StudiesBoston, United States

Inspection team

MMMichelle M Noe

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.108(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 56.109(h)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