Atlas

FDA-Inspected Site

Shire Human Genetic Therapies, Inc.

13 FDA inspections are on record for Shire Human Genetic Therapies, Inc. in Lexington, United States.

483· Form 483 issued

Lexington, United States · Last updated July 10, 2026

Overview

  • 13 FDA inspections are on record.
  • 9 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-12-18.

At a glance

Inspections

13

Form 483s

9

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 Dec 2025 – 18 Dec 2025Human Drugs483On file
29 Mar 2022 – 22 Apr 2022Human Drugs483On file
17 Mar 2022 – 23 Mar 2022Human Drugs483On file
7 Jan 2020 – 15 Jan 2020Human DrugsClean
5 Nov 2018 – 9 Nov 2018Medical Devices & Rad HealthClean
9 Jul 2018 – 25 Jul 2018Human Drugs483On file
12 Dec 2016 – 20 Jan 2017Human Drugs483On file
22 Jul 2015 – 14 Aug 2015Human Drugs483On file
6 May 2013 – 23 May 2013Human Drugs483On file
12 Feb 2013 – 26 Feb 2013Human Drugs483On file
2 Apr 2012Not recordedClean
1 Feb 2012Not recorded483On file

Investigators

FDA investigators tied to this site in the record.

Edmund F Mrak3 insp.
Robert J Martin2 insp.
Sean R Marcsisin1 insp.
Lori M Newman1 insp.
Wayne E Seifert1 insp.
Scott C Lute1 insp.
Rachael O Oyewole1 insp.
MDSAP harperd1 insp.
Michael P Anthony1 insp.
Byungja E Marciante1 insp.
Haley H Seymour1 insp.
John P Mistler1 insp.
Erik W Koester1 insp.
Mary-Jeanet Mcgarry1 insp.
Debra M Emerson1 insp.
Thomas J Arista1 insp.
Megan A Haggerty1 insp.
Ellen P Madigan1 insp.
Ramon E Martinez1 insp.
Michelle M Noe1 insp.

Full site report

Get the verbatim findings behind Shire Human Genetic Therapies, Inc.'s 9 Form 483s

The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat