Alfasigma SpA - June 21, 2018
Issue Date
Jun 21, 2018
Region
HQ
Category
Drug
$117.00
Contact Name
Marco Maioli
Contact Title
Operations Manager & Plant Deputy Director
Address 1
Via Pontina, Km 30,400
City
Pomezia, Rome
Zip/Postal Code
00071
Country
Italy
Inspection Range
Jun 14, 2018 - Jun 21, 2018
Pages
6
First Observation
There are no smoke studies conducted to evaluate airflow patterns and to qualify/show unidirectional air flow in filling line … when the line is used for the filling of glass vials.
Investigator(s): Jose A. Cruz-Gonzalez