Bayer Warned About Quality of Drugs Made at German Plant

The Food and Drug Administration has warned drug maker Bayer AG about concerns the agency has about the quality of drugs made at one of the company’s German manufacturing facilities.

In a letter sent to Bayer last month, the FDA said it has concerns about how the drug company monitors and tests its drugs for quality. A March 2009 inspection of the Bayer plant in Bergkamen, Germany revealed problems with Bayer’s system of quality control, the FDA said.

“We remain concerned with your released and distributed API (active pharmaceutical ingredients) batches used in the manufacture of finished products intended for the U.S. market,” the FDA wrote in the letter, according to a Reuters news report.

The Bergkamen production facility makes ingredients for various pharmaceutical chemicals used in steroid hormones, Bayer said. There is no word from the FDA about specific drugs that stem from the Bayer facility or reports of injuries from products made there.

Bayer Not Doing Enough to Fix Problems

The FDA said that while Bayer promised to address the concerns raised after the inspection and vowed to improve the quality control at the plant, corrective steps taken by the company do “not adequately address some of the deficiencies.”

Bayer said it is still working on addressing the FDA’s concerns but insisted that every Bayer product undergoes a strict quality evaluation before it is released to consumers.

“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,” Bayer spokeswoman Rose Talarico said in an emailed statement, according to Reuters.

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