Atlas

FDA-Inspected Site

Shire Manufacturing US Inc.

3 FDA inspections are on record for Shire Manufacturing US Inc. in Lexington, United States.

483· Form 483 issued

Lexington, United States · Last updated July 11, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2009-12-04.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
4 Dec 2009Not recorded483On file
20 Nov 2009Not recorded483On file
5 Mar 2009Not recordedClean

Investigators

FDA investigators tied to this site in the record.

Rory Geyer2 insp.
Kalavati C Suvarna1 insp.
Robert C Horan1 insp.
Richard H Penta1 insp.

Full site report

Get the verbatim findings behind Shire Manufacturing US Inc.'s 2 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