Atlas

Form 483

Joslin Diabetes Center Committee on Human Studies Form 483, 2014-06-27

FDA issued a Form 483 to Joslin Diabetes Center Committee on Human Studies on 2014-06-27 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Joslin Diabetes Center Committee on Human Studies · Boston, United States · Issued June 27, 2014

Overview

  • 1 public-safe observation is 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.

27 Jun 2014
21 CFR 56.109(b)

Information given to subjects

Cited by Kent A Conforti

Inspected site

JDJoslin Diabetes Center Committee on Human StudiesBoston, United States

Inspection team

KAKent A Conforti

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

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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