FDA Warns Bayer About Testing At German Plant

Law360, New York (September 16, 2009, 7:37 PM EDT) -- The U.S. Food and Drug Administration has warned Bayer AG to tighten its testing and quality monitoring procedures at a German facility, issuing a letter advising the company to amend its standards to comply with the agency's good manufacturing practices.

The FDA released a warning letter Sept. 15 sent to the manager of a Bayer supply center in Bergkamen, Germany, on Aug. 5 after an eight-day agency investigation of the plant in March turned up “significant deviations” from the agency's accepted standards for the manufacturing of...
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