Drug Maker Bayer Gets FDA Warning Letter

As a result of its March 2009 inspection of Bayer’s German plant located in Bergkamen, the FDA has sent the pharmaceutical company a warning letter concerning its quality control procedures at the manufacturing plant.
The FDA letter warned, “”We remain concerned with your released and distributed API batches used in the manufacture of finished products intended for the U.S. market.” While Bayer downplayed the issue, company spokeswoman did say they were taking steps to address the concerns delineated in the warning letter. Bayer was also quick to state that the substance of the warning letter revealed no consumer safety threat. “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.