Quoted from http://www.nytimes.com/aponline/2009/09/15/us/politics/AP-US-Bayer-FDA-Warning.html
FDA Warns Bayer Over German Manufacturing Plant
By THE ASSOCIATED PRESS Published: September 15, 2009
WASHINGTON (AP) -- U.S. health regulators have warned drugmaker Bayer over quality control issues at a plant that makes the key ingredient in Yaz and other popular birth control drugs.
In a warning letter posted online Tuesday, the Food and Drug Administration said its inspectors uncovered testing problems at the company's plant in Berghamen, Germany, during a March visit.
FDA inspectors said the company measured the quality of its drug ingredients based on an average of several samples, instead of reporting individual tests results.
Bayer shipped eight drug batches to the U.S. that were tested using the method, which the FDA does not accept.
The drug ingredients included drospirenone, which is used in the popular birth control pills Yaz and Yasmin. Those products were the company's top-selling pharmaceuticals last year, with global sales of $1.8 billion.