Bioconnection BV - March 4, 2020
Issue Date
Mar 04, 2020
Region
HQ
Category
Drug
$117.00
Contact Name
Alexander Willemse
Contact Title
CEO
Address 1
Kloosterstratt 9ry
City
Oss
State
Noord-Brabant
Zip/Postal Code
5349 AB
Country
Netherlands
Inspection Range
Feb 26, 2020 - Mar 04, 2020
Pages
9
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
Investigator(s): Omotunde O. Osunsanmi