FDA Berates Bayer for Inadequate Cleaning, QC Questions at HQ

The company is addressing the FDA’s complaints regarding manufacturing practices, which stem from a routine inspection in January,


FRANKFURT (Reuters) - Bayer said it had received a warning letter from the U.S. Food and Drug Administration (FDA) 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.

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