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Form 483

Somerset Medical Center IRB Form 483, 2026-03-11

FDA issued a Form 483 to Somerset Medical Center IRB on 2026-03-11 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Somerset Medical Center IRB · Somerville, United States · Issued March 11, 2026

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.

11 Mar 2026
21 CFR 56.108(c)

Approval from a majority of members present

Cited by Jay B Shah

Inspected site

SMSomerset Medical Center IRBSomerville, United States

Inspection team

JBJay B Shah

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.108(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

The full inspection record, as Atlas holds it, 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