Antibioticos Do Brasil - Aug. 28, 2018
Issue Date
Aug 28, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Marco Bosoni
Contact Title
President
Address 1
Rod Professor Zeferino Vaz, Km 135, Itapavassu
Address 2
Cosmopolis
City
Sao Paulo
Zip/Postal Code
13150-000
Country
Brazil
Inspection Range
Aug 20, 2018 - Aug 28, 2018
Pages
6
First Observation
Environmental monitoring procedures executed during the aseptic filling of sterile drug products ... were found inadequate to assure a thorough assessment of the microbiological conditions of the environment in which product aseptic filling operations are taking place.
Investigator(s): Jose A. Cruz Gonzalez