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