Unapproved Quality Methods Land Sandoz Subsidiary An FDA Warning

June 14, 2013
Sandoz subsidiary Ebewe Pharma has been warned for distributing parenteral drug products to the U.S. that were made using quality control methods not included in an approved application. The maker of generic oncology injectables “used unapproved procedures for visual inspection prior to obtaining approval of a supplement regarding these changes,” the FDA said in the letter.
Washington Drug Letter