WHAT IS THE MEANING OF “ADULTERATEDâ€? Pharma Evolution just released an "abridged" Blog, "WHO, TGA & MHRA: Just What Does the Word 'Adulterated' Mean?" (see below).() Should you wish to read and comment on this abridged version, please go to the location listed above. To view the total Blog, continue reading … [Read more...]
INDIAN MANUFACTURING FACILITIES CONTINUE TO RECEIVE FDA REGULATORY ACTIONS
HOSPIRA'S IRUNGATTUKOTTAI FACILITY RECEIVES WARNING LETTER (052813) Recently Ranbaxy settled a $500 million lawsuit with the Dept. of Justice for selling improperly manufactured and tested drugs (see previous Blogs). More recently, Maharashtra-based Wockhardt received an Import ban (see previous Blogs to learn of what other Indian based … [Read more...]
Ranbaxy Labs Gets A Sweeping Consent Decree (01/25/12)
RANBAXY REQUIRED TO PAY $500 MILLION FINE COMMENT Ranbaxy Laboratories entered into a Consent Decree with the FDA on January 25, 2012 wherein they agreed to pay a $500 million fine and accept changes to plants both within the US and India. This Blog has previously reported on a number of on-going issues to include the falsification of data … [Read more...]
AUROBINDO PHARMA LIMITED, UNITS III AND VI, RECEIVE WARNING LETTER (MAY 20, 2011)
 AUROBINDO PHARMA RECEIVES IMPORT BAN FOLLOWED BY WARNING LETTER  -- AN UNUSUAL SEQUENCE OF EVENTS COMMENT The receiving of an Import Ban prior to receiving a Warning Letter has not been a common occurrence. However, because of the FDA's recent and previous audits, and the lack of continuing compliance, … [Read more...]
PHARMACEUTICAL COMPANY JELFA SA (POLAND) RECEIVES WARNING LETTER (7/14/11) PART II
JELFA SA FAILS TO FOLLOW FDA'S ASEPTIC PROCESSING GUIDANCE FOR INDUSTRY (SEPTEMBER 2004)  2. Your firm has not established appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile [21 C.F.R. § 211.113(b)]. For … [Read more...]
