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The Food and Drug Administration says that its inspectors discovered testing problems at the company's plant in Berghamen, Germany. FDA inspectors claimed that the company measured the quality of its drug ingredients based on an average of several samples, instead of reporting individual tests results (Perrone, 2009).
Bayer produces the popular birth control pills Yasmin and Yaz. After reviewing all drug batches of these that were shipped to the U.S. between 2007 and 2009, Bayer responded to the FDA in an April saying that the quality of those batches were not affected. The FDA on the other hand disagreed with Bayer's conclusion. The FDA has asked Bayer to supply a full list of all shipments to the U.S. In which they used the averaging method and provide a plan to prevent the problem from recurring. The FDA said it will consider delaying imports from the factory until Bayer complies with the warning letter (Perrone, 2009).
The FDA frequently...
The letters are not legally binding, but the agency can take companies to court if they do not comply. The FDA has recently made several changes it their process designed to speed the pace of warning letters. This included a streamlined review process for sending the letters and shorter deadlines for companies to respond (Perrone, 2009).
This is good example of how constraints are put on the production of items. In this case the constraints are put into place in order to protect the health of those people who will be consuming the drugs that are being made.
References
Perrone, Matthew. (2009). FDA warns Bayer over German manufacturing plant. Retrieved September 18, 2009, from Business Week Web site:
http://www.businessweek.com/ap/financialnews/D9ANQR7O0.htm
Reference List
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