483sOnline Subscribe

Search By Date Issued

Search By Category

Drug
Device
Clinical

Search By Company/

Clinical Investigator

Search By Region

Search By FDA Investigator

Search By Keyword

Log in to start searching through our library of thousands of 483s, or Subscribe Now to 483sOnline.com to uncover exactly what FDA Inspectors are thinking about. It’s your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on so you can be prepared – before they show up.

Shire Human Genetic Therapies, Inc. - Feb. 1, 2018

Issue Date

Feb 01, 2018

Region

Northeast

Category

Drug
$117.00

Shire Human Genetic Therapies, Inc.

Contact Name

James M. Payne

Contact Title

Head of Lexington Manufacturing Site

Form483 Address 1

185 Alewife Brook Parkway

Form483 Address 2

Form483 City

Cambridge

Form483 State

MA

Form483 Postal

02138

Form483 Country

United States

Inspection Range

Jan 16, 2018 - Feb 01, 2018

Pages

1

First Observation

You do not document all investigations of manufacturing deviations that may have an adverse impact on process and drug substance product quality.
Investigator(s): Sean R. Marcsisin, Edmund F. Mrak