Ipsen Biopharm Ltd. - Sept. 12, 2017
Issue Date
Sep 12, 2017
Region
HQ
Category
Drug
$117.00
Contact Name
Gareth R. Quinn
Contact Title
Quality Director
Address 1
Unit 418, Ash Rd. North
City
Wrexham, Clwyd
Zip/Postal Code
LL139UF
Country
United Kingdom
Inspection Range
Sep 04, 2017 - Sep 12, 2017
Pages
6
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Investigator(s): Susan Hadman and Shawn E. Larson