With reference to the earlier announcement dated February 26, 2013 regarding US FDA inspection resulting in putting on hold the production at Company?s API plant located at Kalyani, District Nadia, West Bengal, (India) and subsequent warning letter dated July 01, 2013, asking for certain other information and implementation of more corrective and preventive measures so as to avoid recurrence of deviations, Fresenius Kabi Oncology Ltd has now informed BSE that in view of the observation made by US FDA, the Company had initiated necessary corrective and preventive steps for improving quality control parameters and preventing recurrence of such deviations at the Plant in future. A lot of steps have either been implemented or in the advance stage of implementation.
According to different remediation activities, subsequent review of corrective steps and reviewing the current scenario at the plant, it has now been decided to resume the production at Kalyani plant in a phased manner.
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