Shire U.S. Manufacturing, Inc. - Dec. 2, 2012
Issue Date
Dec 02, 2010
Region
Central
Category
Drug
$117.00
Address 1
1120 Gundry Lane
City
Owings Mills
State
MD
Zip/Postal Code
21117
Country
US
Inspection Range
Nov 15, 2010 - Dec 02, 2010
Pages
3
First Observation
In-process specifications are not consistent with drug product final specifications.
Investigator(s): Rachel C. Harrington and Nebil A. Oumer