Donald Ashley, JD, Director of the Office of Compliance at CDER reported a rather surprising statistic relative to the country that received the most warning letters in FY 2019! And the winner is – the United States! Domestic firms received 54 warning letters, followed by India with 17 and China with 14. Previous years had India or China with the dubious distinction of being issued the most warning letters. It is not clear if this relates to the number of foreign inspections or that compliance issue in US firms have taken a downturn.
Mr. Ashley spoke about the issue of data integrity (DI) being one of the big issues, with a significant impact on drug product quality. In FY 2018, 34 of 94 warning letters cited DI issues, and in FY 2019 there were 32 of 98 warning letters addressing DI.
Don also discussed the nitrosamine impurity issues relative to valsartan and ranitidine and the FDA investigation of how the problem occurred. He cited Dr. Janet Woodcock’s statement regarding this issue: “Americans deserve to have confidence in the quality of drugs the U.S. Food and Drug Administration regulates –from the prescription medicines they take to the over-the-counter (OTC) products they use in their daily lives.” Quality is a continuous attention to detail, cGMPs, and culture.