Fresenius Kabi Oncology gets warning letter from US FDA

Fresenius Kabi Oncology has received a warning letter from US FDA, asking for certain other information and implementation of more corrective and preventive measures so as to avoid recurrence of deviations. Company had put on hold the production at API plant located at Kalyani, District Nadia, West Bengal, (India)
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Jul 06, 2013, 04.28 PM | Source: Moneycontrol.com

Fresenius Kabi Oncology gets warning letter from US FDA

Fresenius Kabi Oncology has received a warning letter from US FDA, asking for certain other information and implementation of more corrective and preventive measures so as to avoid recurrence of deviations. Company had put on hold the production at API plant located at Kalyani, District Nadia, West Bengal, (India)

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Fresenius Kabi Oncology gets warning letter from US FDA

Fresenius Kabi Oncology has received a warning letter from US FDA, asking for certain other information and implementation of more corrective and preventive measures so as to avoid recurrence of deviations. Company had put on hold the production at API plant located at Kalyani, District Nadia, West Bengal, (India)

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With reference to the earlier announcement dated February 26, 2013, regarding putting on hold the production at Company's API plant located at Kalyani, District Nadia, West Bengal, (India) in view of certain observations made by US FDA in respect of manufacturing, documentation practices and product testing during a routine inspection, Fresenius Kabi Oncology Ltd has now informed BSE that the Company has received a warning letter from US FDA, inter-alia, asking for certain other information and implementation of more corrective and preventive measures so as to avoid recurrence of deviations.Source : BSE

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