The U.S. Food and Drug Administration has warned Merck & Co. that it has 15 days to correct violations at its plant in West Point, PA.
The FDA issued a 9 page warning letter which requires Merck to detail how it plans to correct the violations or face the suspension of the plants manufacturing license and the possibility of the seizure of products.
The plant manufactures various children's vaccine and Gardasil, the vaccine that protects against cervical cancer. Last year, Merck was recalled 1.2 million vaccine doses due to a problem with sterility.
The entire waring letter, with all infractions, can be found on the FDA website. Warning letter to Merck & Co dated April 28, 2008.
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FDA inspectors spent 30 days at the plant between November and January and cited 49 areas of concern, including a failure to follow good management practices, the paper writes. The findings are detailed in an unpublished 21-page FDA report obtained by The Inquirer under the federal Freedom of Information Act. UPDATE On April 30, the FDA released this nine page warning letter. Independent experts who reviewed the report say it documents serious concerns in one of the country’s premier vaccine plants, the Inquirer writes, and they suggested the problems could be a symptom of Merck’s cost cutting in the face of rapid growth of its vaccine business. “I would fault the management for not providing enough resources to do the work that needs to be done,” Scott M. Wheelwright, a biotech manufacturing expert and chief executive officer of the biotech consulting firm Strategic Manufacturing Worldwide, tells the paper.
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