FDA Discovers Problems at PA Merck Plant

April 2008

Another red flag has been raised in the increasingly scrutinized drug manufacturing industry. Results of a Food and Drug Administration (FDA) investigation reported almost 50 "areas of concern" in Merck’s West Point, Pennsylvania vaccine manufacturing plant. The agency’s report cited a number of issues that can pose safety risks to consumers.

Two of the 49 infractions listed by the FDA were finding undesirable "fibers" on the stoppers of MMR vaccine as well as Merck’s failure to follow good manufacturing procedure. The Pennsylvania facility is a major vaccine manufacturing hub for Merck, and the report was issued just as the company’s vaccine business is thriving. Merck has introduced several new products in the past few years, including Gardasil, the highly publicized HPV vaccination. According to some in the industry, this growth may make it difficult for plant technicians to keep pace.

John T. McCubbins, director of Merck’s Global Vaccine Manufacturing and West Point Operations, disputed this claim. He said that no contamination was found in finished vaccines and that Merck’s own technicians detected many of the issues that were raised during the FDA’s investigation.