Bayer received a warning letter from FDA

| By | Bayer, Drug Manufacturing, FDA

Bayer said it had received a warning letter from the U.S. Food and Drug Administration over how it handled production of some drugs at its Leverkusen, Germany headquarters.

The German drugmaker, which is taking over U.S. seed maker Monsanto, is addressing the FDA’s complaints regarding manufacturing practices, which stem from a routine inspection in January, Bayer said. It has no evidence that patient safety was or is at risk and no products would be recalled, it added.

“We expect temporary supply limitations affecting our mature product portfolio,” though distribution from the Leverkusen supply center would continue, Bayer said.

A spokesman said this was affecting the established drugs Adalat against high blood pressure, blood thinner Aspirin Cardio, antibiotic Avelox, and potency drug Levitra.

SOURCE: reuters
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