In a letter released yesterday, the Food and Drug Administration (FDA) said it had issued the warning after a March inspection at the facility raised concerns about Bayer’s ability to monitor the quality of the active pharmaceutical ingredients it makes.
In April, when the firm first became aware of the concerns, Bayer said it was moving to rectify the problems. However, in the latest letter the FDA said that the measures were insufficient.
The agency wrote that: “We remain concerned with your released and distributed active pharmaceutical ingredients (API) batches used in the manufacture of finished products intended for the US market."
Bayer said it will look at the FDA’s list of concerns and is working to prepare a response.
The firm also told Reuters that: “Based on our assessment at this point in time, we have identified no safety and efficacy impact on our products in relation to the [good manufacturing practice] issues as cited by the FDA.”
Although he is not due to take over as CEO until 2010, the FDA warning letter will not have escaped the attention of Marijn Dekkers, particularly as news of it broke on the day his succession was announced.
Dekkers takes over from current incumbent Werner Wenning, who is stepping down in October 2010, and will head Bayer’s health care products unit until the transition is complete.
In a recent Reuters interview, Wenning said that: “It looks like Bayer is getting prepared for corporate transformation. Dekkers is an expert in corporate restructuring. By focusing on health care, investors could have more visibility on each single element.”
This resulted in considerable market speculation about Bayer’s future and whether the appointment of someone from outside the company for the first time may change how it approaches the drug and chemical industries.
Citigroup analyst Andrew Benson said: “Acquisitions under Wenning’s leadership were all transformational and critical to Bayer’s recovery, however he remained wedded to its conglomerate structure,” adding that “Dekkers should bring new thinking.”