The FDA hit Rotterdam, Netherlands-based drugmaker Fagron for inadequate drug product storage and procedures for controlling recalled products at the firm’s Saint Paul, Minn., facility. Read More
The FDA slapped Xellia Pharmaceuticals with a Form 483 after finding quality and sterility shortcomings during a May inspection of its Copenhagen facility. Read More
The FDA hit two Medtronic device facilities with warning letters last week, citing faulty device history records and CAPA procedures. Read More
Lack of design change procedures and validation as well as inadequate complaint handling resulted in a 483 for German devicemaker Alber during an inspection of the firm’s facility in Albstadt, Baden-Wurttemberg. Read More
300 N Washington St., Suite 200, Falls Church, VA 22046, USA.
Phone (703) 538-7600 – Fax (703) 538-7676 – Toll free (888) 838-5578.
Copyright ©2018. All Rights Reserved.
Design, CMS, Hosting & Web Development :: ePublishing