Statement regarding FDA inspection of Ranbaxy’s Toansa plant
Posted: 14 January 2014 | | No comments yet
Ranbaxy received the form 483 with certain observations as a result of the recent US FDA inspection at its API plant at Toansa, Punjab, India…
Below is the statement by Ranbaxy Laboratories Ltd., a subsidiary of Daiichi Sankyo Co., Ltd., which was issued on January 13, 2014.
On Saturday, January 11, 2014, Ranbaxy received the form 483 with certain observations as a result of the recent US FDA inspection at its API plant at Toansa, Punjab, India. The Company is assessing the observations, and will respond to the US FDA in accordance with the agency’s procedure to resolve the concerns at the earliest.
Ranbaxy continues to improve its systems and processes, and remains fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect from the Company. Ranbaxy stays firmly committed to its philosophy of ‘Quality and Patients First’.