Fresenius says warned by FDA on Puerto Rico plant
FRANKFURT Aug 23 (Reuters) - Diversified healthcare group Fresenius said it was told in a warning letter by the U.S. Food and Drug Administration (FDA) to improve procedures at a blood bag manufacturing plant in Puerto Rico.
The FDI took issue with complaint-handling procedures and labeling, the German company said on Friday, adding patients had not been put at risk.
It added it was addressing the issues cited in the warning letter and that production at the plant was continuing.
It said it did not expect a material impact on sales and earnings at its infusion drugs and blood transfusion unit Kabi, confirming Kabi's full-year outlook.
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