Quality Management Performance Data Summary 2005–2008

	2008	2007	2006	2005
Number of product recalls in United States	0	2	0	1

Vaccine Supply

Over the past few years, Merck has experienced a number of challenges in manufacturing that have prevented us from being able to meet global demand for a number of our vaccines. As a result, some of our vaccines have been on backorder and other of our vaccines have been unavailable for order for some time.

We are working to correct these issues and to regain our position as a dependable vaccine manufacturer and supplier. In the past three years, Merck has invested over $1 billion in new manufacturing resources to ensure that we have the long-term supply capabilities to meet public health needs around the world. Specifically, we are currently modernizing some of our processes and equipment at our facility in West Point, Pennsylvania, expanding vaccine manufacturing in Virginia and France, and we have two new facilities under construction in North Carolina and Ireland. Our goal is to have additional manufacturing capacity and to create redundancy in our supply chain for certain products so that we will not experience supply disruptions when temporary issues arise in the manufacture of our vaccines.

Some of these planned changes will take time. Nevertheless, we are committed to the development and commercialization of vaccines and re-establishing ourselves as a reliable supplier of vaccines.

West Point Manufacturing Operations

In early 2008, the FDA inspected Merck's West Point vaccines and biologics manufacturing facility. At the conclusion of the inspection, the FDA issued a report containing 49 observations from their visit. Subsequently, Merck received a Warning Letter from the FDA dated April 2008.

Merck took the observations and the Warning Letter very seriously and committed to addressing all concerns to the Agency's satisfaction. Importantly, the issuance of the Warning letter did not affect any available product or Merck's ability to continue to supply our vaccines.

In July 2008, Merck received a letter from the FDA closing out its inspection of the West Point facility. Following subsequent inspections by the Agency, we continue to work with the agency in a cooperative manner to ensure that we have robust processes and procedures in place to produce vaccines and sterile products to the highest standards.

Recalls

In 2008, Merck had no product recalls in the United States.

Merck takes its responsibility to public health and product safety very seriously. We have taken, and will continue to take, appropriate action to ensure the safety and efficacy of our medicines and vaccines.

The content on this page was last modified on September 15, 2009.

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