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Feb 27, 2013, 11.51 AM IST
During a recent routine inspection USFDA made certain observations relating to GMP non-conformities in respect of manufacturing, documentation practices and product testing. The Company has immediately taken steps to implement remedial measures and has voluntarily put the production on hold at Kalyani, District Nadia, West Bengal, (India).
Fresenius Kabi Oncology Ltd has informed BSE that during a recent routine US FDA inspection at Company’s API plant located at Kalyani, District Nadia, West Bengal, (India), US FDA made certain observations relating to GMP non-conformities in respect of manufacturing, documentation practices and product testing. However, all finished products conform to approved standards and specifications.The Company has immediately taken steps to implement remedial measures and has voluntarily put the production on hold. The Company’s dosage form plants in Himachal Pradesh continue normal production.Source : BSE
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