FDA PROVIDES NO RATIONALE FOR ALERT After the Warning Letter for Zhejiang Jiuzhou Pharmaceutical Co. was published in a recent Blog (8/20/14), several of my colleagues sent me comments regarding this Chinese Active Pharmaceutical Ingredient (API) source. They were particularly intrigued by the Blog because one had observed an Import Alert that was issued by the FDA on March … [Read more...]
FDA PROHIBITS INDIAN FACILITY FROM PRODUCING AND DISTRIBUTING DRUGS FOR U.S. MARKET
ANOTHER RANBAXY FACILITY IS ADDED TO EXISTING CONSENT DECREE The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical  ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products. The Toansa facility is now … [Read more...]
