Objectionable Anaerobe Found During Customer Sampling During the FDA’s inspection of VUAB Pharma a.s., Vltayska 53, Roztoky, Czech Republic, from June 09, 2014, through June 13, 2014, an investigator from the U.S. Food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active … [Read more...]
ZHEJIANG JIUZHOU PHARMACEUTICAL CO. RECEIVES IMPORT ALERT (3/18/14)
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 Warning Letters – Their Relationship to Drug Shortages — An Interesting Counterpoint
Recently (June 12, 2014) I authored a Blog re: “FDA Warning Letters – Their Relationship to Drug Shortages”. This Blog elicited several very interesting comments. Within this Blog, I noted that Douglas C. Throckmorton, MD, Deputy Director for Regulatory Affairs, CDER, FDA recently presented at the ISPE meeting on June 4, 2014 where he discussed this topic and illustrated the … [Read more...]
FIND FDA WARNING LETTERS AND RECALLS THAT DISCUSS THE LATEST REGULATORY THOUGHTS
USE “KEY WORDS’ THAT PROVIDE FOCUSED SEARCHES Barry A Friedman, PhD has been publishing a variety of Regulatory Actions including information regarding Warning Letters, Recalls, and other regulatory activities for over three years. These 140+ Regulatory Actions often include FDA related activities that are not readily found within the FDA … [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...]
