Shire Human Genetic Therapies, Inc. - April 22, 2022
Issue Date
Apr 22, 2022
Region
Northeast
Category
Drug
$117.00
Contact Name
James M. Payne
Contact Title
Vice President and Head MA Bio Ops.
Address 1
300 Shire Way
City
Lexington
State
MA
Zip/Postal Code
02421-210I
Inspection Range
Mar 29, 2022 - Apr 22, 2022
Pages
2
First Observation
The Quality Unit failed to adequately assess the impact of … Chromatography Systems (HPLC … & HPLC …) that had not undergone routine calibration since their initial qualification in 2014, to analytical testing of glycan mapping for Velaglucerase Alfa Drug Substance and Idursulfase Drug Substance and Drug Product.