FDA Investigator

Michael C Kennedy

Latest inspection on record: Toluca, Mexico, August 2018

Biologics

FDA inspection record · Last updated July 12, 2026

Overview

  • 3 inspections across 3 sites are on record.
  • 1 Form 483 observation is attributed to this investigator.
  • Most recent recorded activity is 2018-08-03.

At a glance

Inspections

3

Sites

3

Observations

1

Career since

Mar 2018

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
Laboratorios Silanes, S.A. de C.V.3 Aug 2018BiologicsOn file
Prothya Biosolutions Netherlands B.V.30 Mar 2018BiologicsOn file
Baxalta US Inc.2 Mar 2018BiologicsOn file

Sites inspected

Laboratorios Silanes, S.A. de C.V.Toluca, Mexico1 insp.
Prothya Biosolutions Netherlands B.V.Amsterdam, Netherlands1 insp.
Baxalta US Inc.Social Circle, United States1 insp.

Co-investigators

Investigators who share inspections with this person.

Cecily M Jones1 shared
Silvia Wanis1 shared
Yonggang Wang1 shared
Lily Y Koo1 shared
Deborah M Trout1 shared
Donald B Ertel1 shared
Susan M Jackson1 shared

Full investigator report

Get the verbatim findings behind Michael C Kennedy's 1 observation

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

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