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Fresenius Kabi Hit With Two Warning Letters At Sites In India In December

 
• By Joanne S. Eglovitch

New Year’s resolutions anyone? Generic drug maker Fresenius Kabi closed out the year with the unlucky distinction of receiving not one – but two – drug GMP warning letters from FDA last month. The agency chastised the firm for not reporting failing test results and not getting to the root cause of sterility failures. The firm was also criticized for not learning from earlier mistakes.

Warning Rubber Stamp

FDA in December issued two warning letters to German generic drug maker Fresenius Kabi AG at its sites in India for data integrity problems and inadequate reporting of sterility failures. While the deficiencies were different, the agency chastised the firm for not fixing similar problems noted in earlier inspections.

Both sites make oncology drugs or ingredients for oncology drugs. The first warning letter, which concerned the company’s active pharmaceutical ingredient site in Kalyani, India, was issued on Dec. 4. It follows an inspection conducted last May

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