Sindan Pharma SRL - Jan. 22, 2016
Issue Date
Jan 22, 2016
Region
HQ
Category
Drug
$117.00
Contact Name
Razvan Radu
Contact Title
Site Leader
Address 1
11 Ion Mihalache Blvd.
City
Bucharest
Zip/Postal Code
011171
Country
Romania
Inspection Range
Jan 14, 2016 - Jan 22, 2016
Pages
1
First Observation
Water determination methods by Karl Fischer methods and testing practices are deficient in that they fail to completely document practices and fail to establish that the methods used in testing of samples meet proper standards of accuracy.
Investigator(s): David D. Anderson, Zachary A. Bogorad, Lane V. Christensen, and Frank Wackes