USFDA issues warning letter to Fresenius Kabi

Fresenius Kabi Oncology in Friday said it has received a warning letter from the US health regulator asking for more information and implementation of additional corrective and preventive measures regarding GMP non-conformities.

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"The company has received a warning letter from US Food and Drug Administration (USFDA), inter-alia, asking for certain other information and implementation of more corrective and preventive measures so as to avoid recurrence of deviations," Fresenius Kabi Oncology said in a BSE filing.

On February 26, in a routine inspection at the company's API plant located at Kalyani, West Bengal, USFDA had made observations relating to GMP non-conformities in respect of manufacturing, documentation practises and product testing, it added.

"The company has immediately taken steps to implement remedial measures and has voluntarily put the production on hold," it said.

Shares of Fresenius Kabi Oncology on Friday closed at Rs 106.55 per scrip on BSE, down 0.65 percent from its previous close.