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

Executive Summary

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.

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