Merck Receives Unusual, Holistic Warning Letter from FDA

Merck Receives Unusual, Holistic Warning Letter from FDA

February 16th, 2012 // 2:34 pm @


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.

What is noteworthy is that the FDA made a point of simultaneously inspecting different facilities that fulfill different but highly specific steps along the Merck supply chain. As opposed to merely visiting different plants that make different medications, the agency, in this instance, took a strategic view toward Merck operations that send drugs to the US market. Call it the holistic view.

The move comes, of course, as the FDA is under increasing pressure to bolster its oversight of manufacturing operations in the US and elsewhere in the wake of the Heparin scandal (see this). The White House, for instance, included $10 million in the proposed FDA budget for hiring 19 inspectors to focus just on China, with 16 work there on food and drug safety and standards.

And the FDA was rather clear about the take-away message. The “FDA expects Merck KGaA to undertake a comprehensive and global assessment of your manufacturing operations in all your facilities to ensure global, adequate, and timely resolution of the issues, including making needed improvements to your quality system,” the agency wrote to Merck chairman Karl-Ludwig Kley

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