FDA Warns Pharmaceutical Company About Drugs Manufactured in China

FDA Warns Chinese Ingredients Maker About ‘Basic’ Manufacturing Problems – Pharmalot – WSJ

The Wall Street Journal (1/6, Silverman, 5.62M) “Pharmalot” blog reports that the FDA recently issued a warning letter to Novacyl Wuxi Pharmaceutical facility, a Chinese active pharmaceutical ingredients supplier, in response to manufacturing violations, including an inspection that revealed changes were made to an impurities test sands documentation or justification. The agency also pointed to other issues that called into question the quality of the manufacturer’s ingredients, including an incident in which Novacyl failed to establish lab controls to avoid erroneous data collection and recording. The warning comes amid heightened efforts from the agency to expedite the visa approval process for more US inspectors in China. Fierce Pharma Manufacturing (1/6, Staton, 139) also reports on the warning.