German Merck Receives FDA Warning
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
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.
Posted By
Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
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