German Merck Receives FDA Warning

Mar 12, 2012

After inspecting three Merck KGgA (Merck's Pharmaceutical division in Germany) drug manufacturing plants in Europe last summer, the Food and Drug Administration announced that all three failed inspection. The many manufacturing failures of Merck's plants ranged from failing to establish procedures for preventing microbial contamination to not thoroughly investigating the failure of a batch of product that did not meet specifications. Due to the Heparin scandal, the FDA is under fire to reinforce their authority over manufacturing operations in the US and elsewhere.

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