Ipsen Bioscience, Inc. - Dec. 5, 2017
Issue Date
Dec 05, 2017
Region
Northeast
Category
Drug
$117.00
Contact Name
John P. Kehoe
Contact Title
VP Site Manufacturing Cambridge US, Tech. Ops.
Address 1
1 Kendall Square, Bldg. 709
Address 2
Ste. 7401
City
Cambridge
State
MA
Zip/Postal Code
02139-1562
Country
United States
Inspection Range
Nov 03, 2017 - Dec 05, 2017
Pages
6
First Observation
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): Robert J. Martin and Delaram Moshkelani