Maker of Yaz Warned by FDA about Quality Control Issues at German Plant

The FDA posted a warning letter online this week stating that its inspectors uncovered testing problems at Bayer's plant in Berghamen, Germany. The Berghamen factory makes the key ingredient in Yaz and Yasmin, drospirenone. Yaz and Yasmin were Bayer's top-selling pharmaceuticals last year with global sales of $1.8 billion.

According to the warning letter, Bayer was measuring the quality of its drug ingredients using the wrong method. The FDA requires that individual test results of the quality of ingredients be reported. Bayer had been reporting quality based on an average of several samples instead. The FDA expressly stated that this method of reporting is not permissible.

Eight drug batches from the plant were shipped to the U.S including drospirenone, the progestin used in the birth control pills Yaz and Yasmin.

Bayer denies that there are any safety or efficacy issues with these drug shipments. However, the FDA has asked Bayer to provide a list of all shipments from the Berghamen plant to the U.S. and a plan to prevent the problem from happening again. The FDA said it will consider delaying imports from the plant until Bayer adequately addresses the warning letter.

Bayer has been warned by the FDA about other issues with its popular birth control pills, Yaz and Yasmin. In 2008, Bayer was warned about its Yaz direct-to-consumer advertising. Following that warning, Bayer agreed to a $20 million ad campaign to correct the misinformation contained in its previous marketing.