As quality issues have led to drug shortages, Donald Ashley, director of the FDA’s Office of Compliance, raised several major concerns this week with the active pharmaceutical ingredient (API) industry, noting three trends related to the obfuscation of supply chain information, an increasing number of data integrity question marks and impurity concerns that have led to recalls. On the obfuscation front, Ashley noted that API companies sometimes fail to obtain and retain documents with the identity of the original manufacturer and certificate of analysis. While on data integrity, Ashley noted that of the warning letters issued to API manufacturers over the past four years, 73% have included data integrity charges. Learn More