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Bayer In FDA's Bad Books Over Facility Failures

14 Feb 2018

Not for the first time this decade, the German major has been warned by the US FDA about its manufacturing processes and sorting out the problems could affect supplies of some big-selling products such as the blood pressure treatment Adalat and the erectile dysfunction drug Levitra.

Tablet — The FDA has issued a warning letter over Bayer's testing processes • Source: Shutterstock

Bayer AG has fallen foul of the US Food and Drug Administration's inspection teams and the agency has issued a lengthy warning letter about significant manufacturing violations at the German group's Leverkusen facility that ultimately could affect future approvals.

The FDA has published the warning letter sent in November which relates to an inspection of the Leverkusen plant in...