Shire Human Genetic Therapies, Inc. - Feb. 26, 2013
Issue Date
Feb 26, 2013
Region
Northeast
Category
Drug
$117.00
Contact Name
William F. Ciambrone
Contact Title
Senior VP of Technical Operations
Address 1
300 and 400 Shire Way
City
Lexington
State
MA
Zip/Postal Code
02421
Country
United States
Inspection Range
Feb 12, 2013 - Feb 26, 2013
Pages
2
First Observation
The Quality Assurance Unit has not ensured sufficient mitigation of the risk of introduction of visible protein aggregates intravenously to patients receiving the drug product.
Investigator(s): Megan A. Haggerty