Over the past several years the FDA has issued Warning Letters to a number of aseptic processing facilities that have encountered difficulties with their management of air flow. While the management of airflow appears to be an easy area to manage within the Aseptic Processing Area (APA), the number of Warning Letters (Click Here) has suggested otherwise. The … [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...]
