FDA Investigator

Jay B Shah

Latest inspection on record: West Caldwell, United States, May 2026 · records back to 2021

Human DrugsAnimal Drugs & FeedsMedical Devices & Rad HealthBiologics

FDA inspection record · Last updated July 12, 2026

Overview

  • 45 inspections across 44 sites are on record.
  • 50 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2026-05-19.

At a glance

Inspections

45

Sites

44

Observations

50

Career since

Jun 2021

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
Quagen Pharmaceuticals LLC19 May 2026Human Drugs
Daiichi Sankyo, Inc.4 May 2026Human Drugs
Eric B.J. Segal, M.D.2 Apr 2026Human Drugs
Somerset Medical Center IRB11 Mar 2026Medical Devices & Rad HealthOn file
BeOne Medicines USA, Inc.17 Feb 2026Human DrugsOn file

Sites inspected

Quagen Pharmaceuticals LLCWest Caldwell, United States1 insp.
Daiichi Sankyo, Inc.Basking Ridge, United States1 insp.
Eric B.J. Segal, M.D.Hackensack, United States1 insp.
Somerset Medical Center IRBSomerville, United States1 insp.
BeOne Medicines USA, Inc.Pennington, United States1 insp.

Co-investigators

Investigators who share inspections with this person.

Jonah S Ufferfilge2 shared
Jogy George2 shared
Jordan C Desilva1 shared
Ana C Lazo1 shared
Charlotte P Chang1 shared
Samir C Gala1 shared

Full investigator report

Get the verbatim findings behind Jay B Shah's 50 observations

Source 483 PDFs, verbatim observations, and how each site responded, so your team knows what they cite before they arrive.

  • New inspections and Form 483s, mapped to the CFR citation
  • Warning letter outcomes, and the citation patterns they repeat
  • Their co-investigators, so no surprises about who shows up on site

Related investigators