Aspen OSS B.V. - Sept. 13, 2019
Issue Date
Sep 13, 2019
Region
HQ
Category
Drug
$117.00
Contact Name
Dirk Van Leemput
Contact Title
Site Director
Address 1
Kloosterstraat 6
City
Oss
State
Noord-Brabant
Country
Netherlands
Inspection Range
Sep 09, 2019 - Sep 13, 2019
Pages
4
First Observation
Control procedures are not established which validate the performance of manufacturing, packaging and testing processes that may be responsible for causing variability in the characteristics of drug product test results.
Investigator(s): Guerlain Ulysse