Buchler GmbH - Feb. 16, 2017
Issue Date
Feb 16, 2017
Region
HQ
Category
Drug
$117.00
Contact Name
Christoph Sender
Contact Title
Technical Managing Director
Address 1
Harxbütteler Strasse 3
City
Braunschweig
Zip/Postal Code
D-38110
Country
Germany
Inspection Range
Feb 13, 2017 - Feb 16, 2017
Pages
1
First Observation
There is no assurance that the equipment used in the production of based APIs (including APIs such as which are currently shipped to USA) are always kept in proper conditions for manufacturing operations and to prevent the contamination of the products handled and/or processed in these areas.
Investigator(s): Jose A. Cruz-Gonzalez