Remediation and modernisation plans: Bayer responds to FDA warning

By Dan Stanton

- Last updated on GMT


Related tags Bayer Food and drug administration Pharmaceutical drug

Bayer expects some temporary supply limitations affecting its mature product portfolio as it addresses GMP issues raised in a US FDA warning.

Yesterday, the US Food and Drug Administration (FDA) published a warning letter​ sent to Bayer Pharma AG highlighting problems relating to cleaning procedures and quality control (QC) at its facility in Leverkusen, Germany.

Responding to the warning, Bayer spokesperson Henning Meyer told in-Pharmatechnologist the firm has actively been implementing remediation activities in a timely manner since the FDA’s initial inspection in January 2017 and “is fully committed to diligently addressing the FDA observations.”

However, “due to the ongoing remediation and also modernization measures at the site, we expect temporary supply limitations affecting our mature product portfolio,” ​he told us.

Further details on the remediation and modernization were not revealed, but according to its 2017 annual report​, Bayer set invested to modernise site infrastructure at this facility and one in nearby Wuppertal as part of its €720m capex spend in 2016.

The facility makes a number of pharma products, including oncology drug Nexavar (sorafenib), and cardiology drugs Xarelto (rivaroxaban) and Adalat (nifedipine), though only the latter is off-patent and faces generic competition.

However, Meyer did tell us there is “no evidence that patient safety was or is at risk,” ​and “release and distribution of products from Supply Center Leverkusen continues.”

No comment could be made on the business impact of the warning letter for now, but it will be reflected in Bayer’s upcoming 2018 guidance on February 28, Meyer said.

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