UBI Pharma, Inc. - May 4, 2018
Issue Date
May 04, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Frank Wu
Contact Title
Senior Vice President Pharmaceutical Manufacturing
Address 1
No. 45, Guangfu N. Rd.
Address 2
Hukou Township
City
Hsinchu County
Zip/Postal Code
30351
Country
Taiwan
Inspection Range
Apr 26, 2018 - May 04, 2018
Pages
8
First Observation
There is no assurance that the root causes identified and/or the conclusions derived on investigations dealing with microbial contamination events/deviations ... are properly justified because the investigations do not include and/or start with a proper identification of the microorganism(s) isolated/observed in these events.
Investigator(s): Jose A. Cruz-Gonzalez