"The responsibilities and procedures applicable to the quality control unit are not fully followed Several lists of documents requested were either provided as incomplete, inaccurate and or explained with potentially misleading statements through out the inspection," the FDA inspection report said in one of the observations. "The corporate quality personnel who answered our questions were later found not to have undergone training on the apparent results investigation SOP," it said. We believe none of the observations are related to data integrity. The Company is confident of addressing these issues within the stipulated timeline." Aurobindo shares closed at Rs 465.15 piece on BSE down 1.93 per cent.

Source: Economic Times October 10, 2019 11:15 UTC