There has been news in certain quarters of the market around FDA inspection on one of our sites and the receipt of 483s. We acknowledge that the FDA has carried out an inspection at our EOU Injectable units in Aurangabad and has issued 483s to us.
Wockhardt is fully committed to follow strong quality cGMP system. We have initiated urgently, an accelerated and a comprehensive remedial measure of the observations of USFDA. We have already given full and comprehensive response to FDA. We are determined to achieve full compliance in shortest time.
Date: 15th April 2013