USFDA issues Form 483 to Galena Biopharma (GALE)
USFDA has issued warning letter to galena Biopharma on April 6, 2015. During inspection to Galena Pharma Portland, Oregon facility the U.S. Food and Drug Administration (FDA) has issued a Form 483 Notice of Inspectional Observations (the "Form 483 Notice") noting deficiencies related to post-marketing adverse drug experience reporting and current good manufacturing practices for their only approved products, Abstral and Zuplenz. Galena Pharma has 15 business days to respond to the Warning Letter.
Galena Biopharma is a publicly traded pharmaceutical company based in Portland, Oregon. On this issue Galena Pharma official has stated “We do not expect any interruption in our commercial operations or impact on our 2015 financial guidance as a result of the Warning Letter. However, we cannot give any assurances that the FDA will be satisfied with our response to the Warning Letter or our proposed resolution of the outstanding issues cited by the FDA. Until the issues are corrected, we may be subject to additional regulatory action by the FDA, including the possible withholding or delay of approval of any FDA applications, seizures of our products, and injunctive and civil monetary penalties. Any such actions could disrupt our ongoing business and operations and potentially have a material, adverse impact on our financial condition and operating results".