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Merck KGaA (MKGAF.PK) Receives Highly Unusual, Holistic Warning Letter From FDA


2/16/2012 8:17:12 AM

In what appears to be a calculated review of a supply chain, the FDA last summer inspected three Merck KGgA manufacturing plants in Europe - one that makes active pharmaceutical ingredients, another that makes finished prescription drugs and a third that is responsible for testing meds for the US market - and all three failed the inspections. The details of the assorted manufacturing failures - and there are many details because there were many failures - can be found in a December 15, 2011, warning letter that the FDA has just posted to its web site. They range from failing to establish procedures for preventing microbial contamination to not thoroughly investigating the failure of a batch of product to meet specifications.

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