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...]
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...]
Wockhardt’s Walui and Chikalthana Facilities, Maharasthtra Receive Warning Letter (11/25/13)
Data Manipulation Continues to be a Major Issue After a somewhat quiet month, CDER is again active in India. Their current concern is with a Company that should be familiar to each of us. And the issues in many cases are similar to those found within a Warning Letter issued in July of this year. Alexander Gaffney, RAPS Editor, has put together an excellent summary of this … [Read more...]
WOCKHARDT LIMITED, AURANGABAD, INDIA RECEIVES WARNING LETTER (7/18/13)
FIRM IS CITED FOR WITHOLDING TRUTHFUL INFORMATION AND DELAYING AND LIMITING THE INSPECTION Wockhardt Ltd was recently audited by the FDA during the timeframe of March 18 – 22, 2013 at their Biotech Park, Aurangabad, India. During this audit the FDA documented that Wockhardt Ltd was found to have withheld truthful information, and delayed and limited the inspection. The delay … [Read more...]
