Bayer Side Effects

Bayer FDA Warning Letter

              A warning was issued to Bayer AG’s Bergkamen, Germany facility following an inspection in March resulted in concern among the FDA regarding the pharmaceutical giant’s ability to efficiently test and monitor quality. In the warning letter, dated August 5, 2009, the FDA speaks on the testing processes for the pharmaceuticals and the quality of the ingredients used to make the drugs.

When Bayer responded by indicating they were addressing the issues, the FDA acknowledged the action taken but said the steps did not sufficiently address some of the issues. Inspectors said that Bayer did not measure the drug ingredient quality on individual test results, but rather by utilizing an average of a couple samples. Eight batches of the pharmaceutical, which used the non-acceptable averaging method, were shipped to the United States. The Yaz ingredient, drospirenone, was found which noted that these drugs are marketed by Bayer but also means that the environment that the drugs were made in was mixed.